Medical Device Experience - PatientsVille.org

Data represents reports of adverse events involving medical devices. The data consists of voluntary reports, describing medical devices which may have malfunctioned or caused a death or serious injury. Patientsville.org is scheduled to be updated quarterly and the search page reflects the date of the most recent update. We seek to include all reports received prior to the update. However, the inclusion of some reports may be delayed by technical or clerical difficulties. Data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. DISCLAIMER: Please read and agree to the terms of use here.

-R- MONITOR MCKESSON CORPORATE:PATIENT WAS AN INPATIENT HAVING AN INTERVENTIONAL PROCEDURE. THE PATIENT WAS PLACED ON THE HEMODYNAM
-R- MONITOR MCKESSON CORPORATION:PATIENT WAS AN INPATIENT HAVING AN INTERVENTIONAL PROCEDURE. THE PATIENT WAS PLACED ON THE HEMODYNAM
0.22 MICRON IV FILTER PALL MEDICAL:HYPERAL FLUID NOTED IN BED AND NURSE CHECKING FOR LEAK FOUND A HAIRLINE CRACK IN 0.22 MICRON FILTER.
0/2.5 GAMBRO:PRISMASOL BAG RIPPED WHILE BEING PREPARED IN INTENSIVE CARE UNIT PHARMACY. APPROX 15 DOCUMENTED OCCU
100 ML CADD CASSETTES SMITH'S MEDICAL:CREASES IN CASSETTES.
100 ML TPN BAG BAXA CORP:NURSES HAVE REPORTED THAT THE PORT ON THESE BAGS (THE MIDDLE PORT WHERE MEDICATIONS CAN BE ADDED AFT
100 UNITS/ML, 5ML FILL IN 12 ML SYRINGE MEDEFIL:ON (B) (6) 2010, A NURSING UNIT VOICED A COMPLAINT TO THE PHARMACY THAT IT WAS HAVING PROBLEMS WITH
100ML CADD CASSETTES SMITH'S MEDICAL:INTERNAL BLADDER LEAKING.
100ML CASSETTE SMITHS MEDICAL:CREASES IN CASSETTE.
101025 BIOLITEC:BIOLITEC IS WAITING TO SEE IF THE DEVICE CAN BE RETURNED FOR EVAL. WE HAVE REVIEWED OUR COMPLAINTS S
10ML IN 12 ML SYRINGE MEDEFIL:ON (B) (6) 2010, A NURSING UNIT VOICED A COMPLAINT TO THE PHARMACY THAT IT WAS HAVING PROBLEMS WITH
12F SLS SPECTRANETICS CORP.:MANUFACTURER DATES FOR ALL DEVICES: (B) (4) UNKNOWN.
12F SLS / LLD-EZ SPECTRANETICS CORP.:ANALYSIS: THE DEVICES WERE DISPOSED OF DURING THE CODE AND WERE NOT RETURNED FOR ANALYSIS. THERE WER
1570218|1615519|Y|B|1|01/04/2010|"EPIC SELF-EXPAND 1570218|1615519|Y|B|1|01/04/2010|"EPIC SELF-EXPAND:IT WAS REPORTED THAT DURING AN ILIAC STENTING PROCEDURE, STENT DEPLOYMENT DIFFICULTIES, STENT POSITI
16F SLS SPECTRANETICS CORP.:INDICATION FOR PROCEDURE: ACUTE INFECTION. PROCEDURE: THIS WAS A LEFT-SIDED PROCEDURE PERFORMED IN T
16F SLS / LDD (UNKNOWN SIZE) SPECTRANETICS CORPORATION:INDICATION FOR PROCEDURE: INFECTION. PROCEDURE: THIS WAS A LEFT-SIDED PACEMAKER LEAD REMOVAL PROCEDU
16F SLS / LLD (UNKNOWN SIZE) SPECTRANETICS CORPORATION:MANUFACTURER DATES FOR ALL DEVICES: UNKNOWN.
16F SLS AND LLD#2 SPECTRANETICS CORPORATION:INDICATION FOR PROCEDURE: ACUTE INFECTION POST RE-IMPLANTATION. PROCEDURE: THIS WAS A LEFT-SIDED PRO
18 FR DILATOR/SHEATH COOK MEDICAL:[(B) (4)] DEVICE MANUFACTURED BY COOK MEDICAL.
2-WAY 16 FRENCH FOLEY CATHETER WITH 350 ML URINE M C.R. BARD INC:BARD 2-WAY FOLEY CATHETER BALLOON WOULD NOT DEFLATE, EVEN AFTER CUTTING OFF BALLOON FILL VALVE. SURG
21G ECLIPSE NEEDLE BD:THIS INCIDENT WAS REPORTED ON 01/26/2010. F/U COMMUNICATION WITH THE REPORTER REVEALED THAT THE EVEN
23 GAUGE OCCUTONE ALCON LABORATORIES, INC.:THE SURGEON WAS PERFORMING A VITRECTOMY. THE VITRECTOMY CUTTER BECAME STUCK IN THE CANNULA AND FORC
24G .5" - 7/8" CATHETERS BD INSYTE-N BD MEDICAL:NICU SEEING INCREASE NUMBER OF INFILTRATES SINCE USING BD IV CATHETERS. RESULTING: BLISTERING, SWELL
27G X 4-11/16" WHITACRE SPINAL NEEDLE BECTON DICKINSON CARIBE LTD.:DURING A RACHIA ANESTHESIA, THE NEEDLE REMAINED BLOCKED INSIDE THE PT. THE NEEDLE TIP BROKE AND REMA
29 GA X 8MM PEN NEEDLE BD MEDICAL - INFUSION THERAPY SYSTEMS:MEDICAL PROFESSIONAL REPORTED NURSE WENT TO ADMINISTER INSULIN IN THE PT'S ABDOMEN AND WHEN SHE REMO
2940 NM LASER SCITON, INC.:A CLINICIAN TREATING A PATIENT WITH NON-DISINFECTED PROFRACTIONAL-XC STANDOFF REPORTED THAT THE PATI
3 HOUR RAPID ATTEST BIOLOGICAL INDICATOR 3M CORORATE HEADQUARTERS 3M CTR:I WORK IN SURGICAL SERVICES, STERILE PROCESSING DEPT. WE UTILIZE THE 3M HEALTHCARE STERILIZATION BIO
3 ML 25 GA X 1 INCH JELCO SMITHS MEDICAL, ASD, INC:CLEAN NEEDLESTICK WAS SUSTAINED WHEN AFTER APPROPRIATELY PUTTING THE CAP BACK ON FOLLOWING DRAWING U
3"X3" STERILE PADS ASO LLC:ON (B) (6) 2009, I WAS PREPARING TO CHANGE THE PAD COVERING AN AREA WHICH WAS THE RESULT OF CANCER S
3.5MM LCP PROXIMAL HUMERUS PLATE SYNTHES (USA):ADDITIONAL INFO HAS BEEN REQUESTED. THE DATE OF MANUFACTURE CANNOT BE DETERMINED BECAUSE, THE LOT NU
30 GAUGE ANGLED CANNULA KATENA:A 30 GAUGE ANGLED CANNULA USED DURING EYE SURGERY DISLODGED FROM A 3ML SYRINGE, WITH RESULTING STROM
300W LS INTEGRA LUXTEC, INC.:THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN IN
35-X PROFLEXX AMBULANCE COT FERNO-WASHINGTON, INC.:MANUFACTURER REPRESENTATIVE VISUALLY INSPECTED AND PHOTOGRAPHED STRETCHER AT USER LOCATION. USER REF
4 FRENCH BASIC TRAY WITH SHERLOCK TIP BARD ACCESS SYSTEMS, INC:DURING THE PROCEDURE TO INSERT A SINGLE LUMEN PICC CATHETER, THE HEALTHCARE PROFESSIONAL HAD DIFFICU
4 HOLE PLATE ZIMMER, INC.:PATIENT PRESENTED WITH NON UNION LEFT HIP FRACTURE. THE FAILED HARDWARE IS LISTED BELOW. PREVIOUS S
4-WHEEL WALKER W/A SEAT, ROLLATOR, 500LBS CAPACITY GM HEALTH PRODUCTS, INC.:CUSTOMER SAID, HE SAT DOWN ON HIS WALKER AND WHEELS COLLAPSED, ROLLED OVER BACKWARDS OUT OF WALKER.
5MM BIPOLAR FENESTRATED FORCEPS STRYKER ENDOSCOPY:WHILE PERFORMING A LAPAROSCOPIC TUBAL LIGATION, THE INSTRUMENT, A STRYKER ENDOSCOPY 5MM BIPOLAR FENE
5MM TROCAR US SURGICAL:DURING OPERATIVE LAPAROSCOPY, SMALL PIECE OF ORANGE TROCAR SHAVING FELL IN ABDOMEN. SHAVING OF RETRI
6 FEN TRACH TYCO HEALTHCARE GROUP:AIRLEAK AT END OF INFLATION PORT ON TRACH WOULD NOT ALLOW CUFF TO STAY FULLY INFLATED. THIS PT IS ON
6 FR SHEATH FINUCANE ENTERPRISES:PT HAD UNDERWENT A HEART CATHETERIZATION AND STAFF MEMBER WAS ATTEMPTING TO REMOVE SHEATH FROM PT'S
6F ANGIO-SEAL EVOLUTION ST. JUDE MEDICAL:IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) A 6F ANGIO-SE
6F ANGIO-SEAL STS PLUS ST. JUDE MEDICAL:IT WAS REPORTED THAT FOLLOWING A CORONARY ANGIOGRAM, A 6F ANGIO-SEAL STS PLUS WAS SELECTED FOR USE I
6F ANGIO-SEAL STS PLUS ST. JUDE MEDICAL PUERTO RICO, B.V.:NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS
6F ANGIO-SEAL VIP ST. JUDE MEDICAL:FOLLOWING A PERCUTANEOUS DIAGNOSTIC PROCEDURE, A 6F ANGIO-SEAL VIP WAS DEPLOYED. THE COLLAGEN REMAIN
6F ANGIO-SEAL VIP ST. JUDE MEDICAL PUERTO RICO, B.V.:A FOLLOW UP MEDWATCH WILL BE SUBMITTED AT THE COMPLETION OF OUR INVESTIGATION.
6F ANGIO-SEAL VIP ST. JUDE MEDICAL, INC.:IT WAS REPORTED FOLLOWING A PERCUTANEOUS PROCEDURE, A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE. A PRE-
6F ANGIO-SEAL VIP DEVICE ST. JUDE MEDICAL, INC:IT WAS REPORTED A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE. SOMETIME AFTER DEPLOYMENT, THE PT EXPERIEN
7 MM ENDOSCOPE MAQUET CARDIOVASCULAR:THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE 7 MM ENDOSCOPE LENS W
74MAF ABBOTT VASCULAR-CARDIAC THERAPIES:PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. IT IS LIKELY THAT INTERACTION WIT
760 VENTILATOR COVIDIEN PURITAN BENNETT:AT APPROX 1:40 PM ON (B) (6) 2010, THE VENTILATOR FAILED AND ALARMED. THE PT WAS AMBU-BAGGED IMMEDIA
760 VENTILATOR COVIDIENT PURITAN BENNETT:AT APPROX 2:35 PM ON (B) (6) 2009, THE VENTILATOR FAILED AND ALARMED. THE PT WAS AMBU-BAGGED IMMEDIA
77ETD- MEDTRONIC XOMED, INC.:NO ANALYSIS OF THE PRODUCT CAN BE PERFORMED AS THE EXPLANTED TUBES WERE SENT BY THE PHYSICIAN FOR CU
77ETN MEDTRONIC XOMED, INC.:THIS PRODUCT WAS BEING USED FOR TREATMENT. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES
8.7 BC 14.2 DIAM -2.00 POWER COOPERVISION:I PURCHASED THE FREQUENCY 55 CONTACTS THROUGH (B) (4). OVER THE COURSE OF THE 2 MONTHS THAT I WORE T
800 AMERICAN MEDICAL SYSTEMS, INC.:ON (B) (6) 2006, A TANDEM CUFF AUS DEVICE WAS IMPLANTED. INFO DISCOVERED DURING A REVIEW OF THE PT'S
80FRN HOSPIRA COSTA RICA LTD:THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. (B) (4)
80FRN HOSPIRA COSTA RICA LTD.:THE CUSTOMER CONTACT REPORTED A DISCONNECTION. THE TUBING SET WAS BEING USED FOR AN EPIDURAL DELIVER
80FRN HOSPIRA, INC.:THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR IN PROGRAMMING THE DEVICE, WHICH RESULTED IN THE PAT
80FRN HOSPIRA,INC.:THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR I
80MEA HOSPIRA COSTA RICA LTD.:THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. (B) (4)
80MEA HOSPIRA, INC.:THE CUSTOMER CONTACT REPORTED A DEATH WHILE THE DEVICE WAS IN USE. THE PUMP WAS BEING USED TO DELIVE
80NGT HOSPIRA INC.:.
80NGT HOSPIRA, INC:THE CUSTOMER CONTACT REPORTED AN ADVERSE EVENT WHILE THE DEVICE WAS IN USE. THIS IS A COMBINATION PR
80NGT HOSPIRA, INC.:THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RE
80NGT HOSPIRA,INC.:THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY
84JXG MEDTRONIC NEUROSURGERY:THE RETURNED VALVE WAS PATENT, AND PASSED LEAK AND SIPHON TESTING. HOWEVER, THE VALVE DID NOT MEET R
84JXG UNK:THE DEVICE HAS NOT BEEN RETURNED TO THE MFR.
86 HRH MEDTRONIC XOMED, INC.:THE ATTENDING NURSE REPORTED DURING A CORNEAL TRANSPLANT PROCEDURE, THE DONOR CORNEA WAS DAMAGED BY
868.5440 INVACARE:MFR RECEIVED INFO FROM AN INSURANCE COMPANY ALLEGING THAT AN INVACARE CONCENTRATOR CAUSED A HOUSE FI
87 HRY DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS:THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAMINATION. A SEARCH OF THE
87 JDI DEPUY INTERNATIONAL, LTD.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87 JDI DEPUY ORTHOPAEDICS, INC.:THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER
87 JDL DEPUY ORTHOPAEDICS, INC.:PT REVISED FOR LOOSE ACETABULAR COMPONENT, OSTEOLYSIS AND POLYETHYLENE WEAR.
87 JWH DEPUY ORTHOPAEDICS, INC.:PATIENT WAS REVISED TO ADDRESS FEMORAL LOOSENING. POLY WEAR AND OSTEOLYSIS WERE DISCOVERED INTRAOPER
87 KWA DEPUY INTERNATIONAL, LTD.:PT WAS REVISED TO ADDRESS RECURRENT DISLOCATION. THE CUP WAS SLIGHTLY LOOSE AND RETROVERTED, AND SOM
87 KWA DEPUY INTL, LTD.:PT WAS REVISED TO ADDRESS HEMATOMA AND PAIN. THE ASR CUP AN HEAD WERE REPLACED FOR FEAR OF METAL-ON
87 LPH DEPUY ORTHOPAEDICS, INC.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87FRN HOSPIRA, INC.:THE CUSTOMER CONTACT REPORTED THAT THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CO
87HRS DEPUY ACE S.A. 'R.L.:EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO REVI
87HRS DEPUY ORTHOPAEDICS, INC.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87HRY DEPUTY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS:THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAMINATION. A SEARCH OF THE
87HRY DEPUY (IRELAND):THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87HRY DEPUY INT'L., LTD.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87HRY DEPUY INTERNATIONAL, LTD:THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAMINATION. A SEARCH OF THE
87HRY DEPUY INTERNATIONAL, LTD.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87HRY DEPUY ORTHOPAEDICS, INC.:REVISED FOR PAIN, FOUND ECCENTRIC POLYWEAR.
87HRY DEPUY ORTHOPEDICS, INC.:PATIENT WAS REVISED TO ADDRESS POLY WEAR OF THE LINER.
87HRY DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS:THE PRODUCTS WERE NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY
87HRY DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS, INC.:THE PT WAS REVISED BECAUSE OF PAIN.
87HRY DEPUY-CORK, A DIVISION OF DEPUY ORTHOPEDICS:THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OT
87HRY DEPUY-CORK, A DIVISON OF DEPUY ORTHOPAEDICS:PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE UNI FEMORAL LEADING TO PAIN.
87HRY DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.:PT WAS REVISED TO ADDRESS ECCENTRIC WEAR ON LINER.
87HRY DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, I:THE PRODUCTS WERE NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY
87HRY DEPUY-RAYNHAM, DIV OF DEPUY ORTHOPAEDICS, INC.:PT WAS REVISED TO ADDRESS PAIN.
87HRY DEPUY-RAYNHAM/DIV OF DEPUY ORTHOPAEDICS, INC.:THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAM. A SEARCH OF THE COMPLAI
87HRY DEUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, IN:THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE CO
87HRY; 87NPJ DEPUY ORTHOPAEDICS, INC.:THE COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTI
87HSB DEPUY ACE S.A `R.L:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87HSB DEPUY ACE S.A. 'R.L.:EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE
87HSB DEPUY ORTHOPAEDICS, INC.:THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAMINATION. ALTHOUGH THE EXA
87HSD 87KWS DEPUY FRANCE S.A.:IN 2009, A SPACER WAS IMPLANTED IN THE PT TO ADDRESS CHRONIC DISLOCATION. EIGHT DAYS LATER, THE PT W
87HSD, 87KWS DEPUY FRANCE S.A.:EXAMINATION WAS NOT POSSIBLE AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE F
87HSD, KWS DEPUY ORTHOPAEDICS, INC.:HUMERAL COMPONENT NOTCHED SCAPULA, THE RIM OF HUMERAL STARTED CUTTING SCREW. POLYWEAR AND METALLOSIS
87HSD; 87KWS DEPUY FRANCE S.A.:THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE CO
87HSD; 87KWS DEPUY ORTHOPAEDICS, INC.:EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE
87HSN DEPUY ORTHOPAEDICS, INC.:EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. THE INVESTIGATION WAS LIMITED TO RE
87HWC DEPUY ACE S.A. 'R.L.:EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE
87HWC DEPUY ORTHOPAEDICS, INC.:PT WAS REVISED BECAUSE ALTHOUGH FEMORAL NECK HAD HEALED, THE END OF A 6.5X75MM SCREW WAS TOO LONG AN
87JDG DEPUY INTERNATIONAL, LTD:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87JDG DEPUY INTERNATIONAL, LTD.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87JDG DEPUY ORTHOPAEDICS, INC.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87JDG DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS:PT WAS REVISED TO ADDRESS DISLOCATION. POLY WEAR OF THE LINER DISCOVERED INTRAOPERATIVELY. (B) (6).
87JDG DEPUY-CORK/DIV OF DEPUY ORTHOPAEDICS, INC.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87JDG; 87LPH DEPUY ORTHOPAEDICS, INC.:THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER
87JDI DEPUY CORK, A DIVISION OF DEPUY ORTHOPAEDICS:THE PT WAS REVISED BECAUSE OF BOTH FALLING AND DISLOCATING.
87JDI DEPUY INT'L, LTD.:PT WAS REVISED TO ADDRESS DISLOCATION.
87JDI DEPUY INTERNATIONAL , LTD.:PT WAS REVISED TO ADDRESS DISLOCATION AND INSTABILITY. POLY WEAR DISCOVERED ON LINER INTRAOPERATIVEL
87JDI DEPUY INTERNATIONAL LTD.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87JDI DEPUY INTERNATIONAL, LTD:PATIENT WAS REVISED TO ADDRESS DISLOCATION.
87JDI DEPUY INTERNATIONAL, LTD.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/
87JDI DEPUY INTL LTD:PT REVISED FOR POSTERIOR DISLOCATION OF HEAD AND LINER.
87JDI DEPUY INTL, LTD.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. IT IS STATED IN THE INITIAL PRODUCT INVES
87JDI DEPUY INTL., LTD.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87JDI DEPUY ORTHOPAEDICS, INC.:THE PATIENT WAS REVISED BECAUSE OF OSTEOLYSIS, POLY WEAR OF THE LINER AND LOOSENING OF THE STEM.
87JDI DEPUY-CORK A DIVISION OF DEPUY ORTHOPAEDICS:PATIENT WAS REVISED TO ADDRESS DISLOCATION.
87JDI DEPUY-CORK, A DIV. OF DEPUY ORTHOPAEDCIS:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87JDI DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS:IT WAS FOUND THROUGH X-RAYS THAT THE SLIT OF THE STEM WAS BROKEN. NO REVISION PERFORMED AT THIS TIME
87JDI DEPUY-CORK/DIV OF DEPUY ORTHOPAEDICS, INC.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. IT IS STATED IN THE INITIAL PRODUCT INVES
87JDI DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, I:PATIENT WAS REVISED EARLIER IN THE DAY (REPORTED SEPARATELY). AFTERWARD, IT WAS DISCOVERED THAT TWO
87JDI DEUPY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS:PT WAS REVISED TO ADDRESS FRACTURE OF THE FEMORAL STEM AFTER A FALL.
87JDI JOHNSON & JOHNSON MED (DEPUY - SUZHOU) LTD:THE PT WAS REVISED BECAUSE OF INFECTION, THE STEM WAS REPORTED LOOSE.
87JDI JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD.:PATIENT WAS REVISED TO ADDRESS DISLOCATION.
87JDI JOHNSON & JOHNSON MEDICAL (DEPUY -SUZHOU) LTD.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87JDI JOHNSON & JOHNSON MEDICAL (DEPUY-SUZHOU) LTD.:THE DEVICE ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER
87JDI MEDICAL (DEPUY - SUZHOU) LTD.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE STERILIZATION CERTIFICATION
87JDI 87LPH DEPUY INTERNATIONAL, LTD.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87JDI 87LPH DEPUY INTL, LTD.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87JDI, 87LPH DEPUY INT'L, LTD.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87JDI, 87LPH DEPUY INTERNATIONAL, LTD.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87JDI, 87LPH DEPUY ORTHOPAEDICS, INC.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87JDI, LPH DEPUY INT'L., LTD.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87JDI, LPH DEPUY INTERNATIONAL, LTD.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87JDI, LPH DEPUY INTL, LTD.:PT REVISED TO ADDRESS PAIN.
87JDI, LPH DEPUY INTL., LTD.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87JDI; 87JWH DEPUY ORTHOPAEDICS, INC.:THE PATIENT WAS REVISED BECAUSE OF LOOSENING.
87JDI; 87LPH DEPUY INTERNATIONAL , LTD.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87JDI; 87LPH DEPUY INTERNATIONAL LTD:PT WAS REVISED TO ADDRESS INFECTION. OSTEOLYSIS WAS ALSO REPORTED, AND IT WAS NOTED THAT THERE WAS L
87JDI; 87LPH DEPUY INTERNATIONAL LTD.:THE PT WAS REVISED BECAUSE OF PAIN.
87JDI; 87LPH DEPUY INTERNATIONAL, LTD.:THE PATIENT WAS REVISED BECAUSE OF DISLOCATION.
87JDI; 87LPH DEPUY INTL, LTD:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87JDI; 87LPH DEPUY INTL, LTD.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87JDI; 87LPH DEPUY ORTHOPAEDICS, INC.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87JDL DEPUY ORTHOPAEDICS, INC.:THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER
87JDW DEPUY ORTHOPAEDICS, INC.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87JWH DEPUY (IRELAND):PATIENT REVISED FOR RUPTURED PCL, OSTEOLYSIS AND POLYETHYLENE WEAR NOTED.
87JWH DEPUY CORK, A DIVISION OF DEPUY ORTHOPAEDICS:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87JWH DEPUY INTERNATIONAL, LTD.:THE PT WAS REVISED BECAUSE OF LOOSENING OF THE TIBIAL TRAY.
87JWH DEPUY ORTHOPAEDICS, INC.:PT REVISED FOR POLYETHYLENE WEAR, FOUND DELAMINATION OF INSERT.
87JWH DEPUY RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.:THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAMINATION. A SEARCH OF THE
87JWH DEPUY RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, I:THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE CO
87JWH DEPUY-CORK A DIVISION OF DEPUY ORTHOPAEDICS:NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. A SEARCH
87JWH DEPUY-CORK, A DIV OF DEPUY ORTHOPAEDICS:PT WAS REVISED BECAUSE OF A TIGHT, PAINFUL KNEE.
87JWH DEPUY-CORK, A DIV. OF DEPUY ORTHOPAEDICS:ALTHOUGH THE EXACT DATE OF THE PRIMARY SURGERY IS UNK, IT WAS REPORTED TO HAVE OCCURRED APPROXIMATEL
87JWH DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS:PT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.
87JWH DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS, INC.:EXAMINATION OF THE SUBMITTED DEVICES FOUND EVIDENCE INDICATING POOR ALIGNMENT. THE INVESTIGATION COU
87JWH DEPUY-CORK, A DIVSIION OF DEPUY ORTHOPAEDICS:PT WAS REVISED TO ADDRESS MAL-ALIGNMENT OF THE TIBIA AND LOOSENING.
87JWH DEPUY-CORK, DEPUY ORTHOPAEDICS:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87JWH DEPUY-CORK, DIV OF DEPUY ORTHOPAEDICS:PT WAS REVISED TO ADDRESS PAIN SECONDARY TO COMPONENT MALPOSITIONING.
87JWH DEPUY-CORK/DIV OF DEPUY ORTHOPAEDICS, INC.:THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAM. A SEARCH OF THE COMPLAI
87JWH DEPUY-RAYNHAM - A DIV OF DEPUY ORTHOPAEDICS, INC.:THE PT WAS REVISED BECAUSE OF LOOSENING OF THE TIBIAL AND WEAR OF THE INSERT.
87JWH DEPUY-RAYNHAM - DIV OF DEPUY ORTHOPAEDICS, INC.:THE PT WAS REVISED BECAUSE OF LOOSENING OF THE FEMORAL COMPONENT.
87JWH DEPUY-RAYNHAM, A DEVISION OF DEPUY ORTHOPAEDICS, I:PT WAS REVISED TO ADDRESS TIBIAL LOOSENING AND SUBSIDENCE.
87JWH DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.:THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHE
87JWH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC:PT WAS REVISED TO ADDRESS TIBIAL LOOSENING. POLY WEAR AND OSTEOLYSIS WERE DISCOVERED INTRAOPERATIVEL
87JWH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC.:THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE CO
87JWH DEPUY-RAYNHAM, A DIVISION DEPUY ORTHOPAEDICS, INC.:PT REVISED TO ADDRESS OSTEOLYSIS, POLYETHYLENE WEAR AND LOOSE TIBIA AND FEMORAL COMPONENTS.
87JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS:PT WAS REVISED TO ADDRESS FEMORAL AND TIBIAL SUBSIDENCE.
87JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, I:THE PRODUCTS WERE NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY
87JWH DEPUY-RAYNHAM, A DIVISION OF ORTHOPAEDICS, INC.:PATIENT REVISED TO ADDRESS INFECTION.
87JWH DEPUY-RAYNHAM, A DIVISON OF DEPUY ORTHOPAEDICS, IN:PATIENT WAS REVISED TO ADDRESS FEMORAL LOOSENING.
87JWH DEPUY-RAYNHAM, A DIVSION OF DEPUY ORTHOPAEDICS, IN:PT WAS REVISED TO ADDRESS LIGAMENT LAXITY, INSTABILITY. INTRAOPERATIVELY, DISCOVERED FEMORAL LOOSENI
87JWH DEPUY-RAYNHAM, DEPUY ORTHOPAEDICS, INC.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87JWH DEPUY-RAYNHAM, DIV OF DEPUY ORTHOPAEDICS, INC.:THE PRODUCTS WERE NOT RETURNED FOR EXAM. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER R
87JWH DEPUY-RAYNHAM, DIV. OF DEPUY ORTHOPAEDICS, INC.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87JWH DEPUY-RAYNHAM/DIV OF DEPUY ORTHOPAEDICS, INC.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87JWH, 87JDI DEPUY ORTHOPAEDICS, INC.:THE PRODUCTS WERE NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY
87JWH; 87JDI DEPUY ORTHOPAEDICS, INC.:THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. PRODUCT INFORMATION REQUIRED TO RETRIEVE THE DEVICE HI
87JWT DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, I:THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OT
87JXG MEDTRONIC NEUROSURGERY:(B) (4). THE STEPDOWN CONNECTOR WITH TUBING SHOWED NO ANOMALIES AND PASSED THE PATENCY CHECK. ALTHOU
87KRO DEPUY ORTHOPAEDICS, INC.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87KRO DEPUY-RAYNHAM - A DIV OF DEPUY ORTHOPAEDICS, INC.:THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAM. A SEARCH THE COMPLAINT
87KRO DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.:NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. A SEARCH
87KRO DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, I:EXAMINATION OF THE PACKAGING COMPONENTS CONFIRMED THE REPORTED TEAR IN THE PACKAGE. THE INVESTIGATIO
87KTT DEPUY ACE S.A. 'R.L.:THE PT WAS REVISED BECAUSE THE LAG SCREW PROTRUDED JOINT SURFACES OF FEMORAL HEAD.
87KWA A DIVISION OF DEPUY ORTHOPAEDICS:INFECTION AFTER THIS LENGTH OF TIME IS NOT LIKELY TO INVOLVE A DEVICE OR DEVICE PROCESSING ERROR. TH
87KWA DEPUY FRANCE S.A.:EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE REPORTED PRODUCT/LOT NUMBER WAS PA
87KWA DEPUY INT'L LTD.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87KWA DEPUY INT'L, LTD.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87KWA DEPUY INT'L., LTD.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87KWA DEPUY INTERNATIONAL LTD:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87KWA DEPUY INTERNATIONAL LTD.:PT WAS REVISED TO ADDRESS HIP PAIN.
87KWA DEPUY INTERNATIONAL, LTD:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87KWA DEPUY INTERNATIONAL, LTD.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87KWA DEPUY INTL LTD:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87KWA DEPUY INTL, LTD.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87KWA DEPUY INTL., LTD:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87KWA DEPUY INTL., LTD.:PT REVISED TO ADDRESS PAIN. METALOSIS REPORTED.
87KWA DEPUY ORTHOPAEDICS, INC.:PATIENT REVISED FOR DISLOCATION, OSTEOLYSIS AND POLYETHYLENE WEAR.
87KWA DEPUY ORTHOPAEDICS, LTD.:PATIENT WAS REVISED TO ADDRESS PAIN AND LIGAMENT ISSUES.
87KWA DEPUY-CORK, A DIV OF DEPUY ORTHOPAEDICS:CLINICAL REPORT STATES THE PT WAS REVISED BECAUSE OF REACTIVE SYNOVITIS TO METAL-ON-METAL.
87KWA DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS:PATIENT WAS REVISED TO ADDRESS HIP PAIN. INFLAMMATION LEVELS WERE ELEVATED, BUT THERE WAS NO ACUTE I
87KWA DEPUY-CORK/DIV OF DEPUY ORTHOPAEDICS, INC.:THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER
87KWA DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, I:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87KWA 87LZO DEPUY ORTHOPAEDICS, INC.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87KWA 87LZO 87LPH DEPUY ORTHOPAEDICS, INC.:THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER
87KWA 87LZO 87MEH 87LWJ DEPUY FRANCES S.A.:THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER
87KWA 87MEH 87LZO 87LWJ DEPUY FRANCE S.A.:PATIENT WAS REVISED TO ADDRESS LOOSENING.
87KWA, 87JDI, 87LPH DEPUY INTERNATIONAL, LTD:THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER
87KWA, 87LZO, 87LPH DEPUY ORTHOPAEDICS, INC.:PT WAS REVISED TO ADDRESS A PERIPROSTHETIC FRACTURE.
87KWA, LEH, LZO, LWJ DEPUY ORTHOPAEDICS, INC.:PT REVISED TO ADDRESS INFECTION.
87KWA, LZO DEPUY INTL, LTD.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87KWA, LZO DEPUY ORTHOPAEDICS, INC.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87KWA, LZO DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87KWA, LZO, MEH, LWJ DEPUY FRANCE S.A.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87KWA, LZO, MEH, LWJ DEPUY ORTHOPAEDICS, INC.:PT REVISED FOR LEG LENGTH DISCREPANCY.
87KWA; 87JDI; 87LPH DEPUY INTERNATIONAL, LTD.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. IT IS STATED IN THE INITIAL PRODUCT INVES
87KWA; 87JDI; 87LPH DEPUY INTL, LTD.:PT WAS REVISED TO ADDRESS CHRONIC DISLOCATION.
87KWA; 87LZO DEPUY ORTHOPAEDICS, INC.:PT WAS REVISED TO ADDRESS DISLOCATION DUE TO CUP POSITION.
87KWA; 87LZO; 87LPH DEPUY ORTHOPAEDICS, INC.:PT WAS REVISED TO ADDRESS THIGH PAIN.
87KWL DEPUY ORTHOPAEDICS, INC.:PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM.
87KWL DEPUY-CORK, DEPUY ORTHOPAEDICS:PT WAS REVISED TO ADDRESS PAIN ATTRIBUTED TO STEM LOOSENING.
87KWL DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, I:PAIN, SWELLING, MASS ON MRI, ELEVATED METAL LEVELS.
87KWS DEPUY FRANCE S. A.:REVISION OF SHOULDER PROSTHESIS AS STERN AND EPIPHYSIS DISCONNECTED IN PT.
87KWS DEPUY FRANCE S.A.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87KWS DEPUY FRANCES S.A.:THE PT WAS REVISED BECAUSE THE SCREWS MIGRATED MAKING THE JOINT LOOSE.
87KWS DEPUY ORTHOPAEDICS, INC.:THE PATIENT WAS REVISED BECAUSE OF PAIN.
87KWS, 87HSD DEPUY FRANCE S.A.:EXAMINATION WAS NOT POSSIBLE AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE F
87KWS, HSD DEPUY ORTHOPAEDICS, INC.:PT REVISED FOR PAIN CAUSED BY TOO MUCH ANTEVERSION OF STEM.
87KWS; 87HSD DEPUY FRANCE S. A.:THE PATIENT WAS REVISED BECAUSE OF DISLOCATION.
87KWS; 87HSD DEPUY FRANCE S.A.:THE PT WAS REVISED BECAUSE OF DISLOCATION AND WEAR OF THE CUP.
87KWS; 87HSD DEPUY ORTHOPAEDICS, INC.:PT WAS REVISED TO ADDRESS CHRONIC POSTERIOR DISLOCATION.
87KWT DEPUY ORTHOPAEDICS, INC.:EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO REVI
87KWT 87HSD DEPUY ORTHOPAEDICS, INC.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87KWT, 87HSD DEPUY ORTHOPAEDICS, INC.:EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FO
87KWT; 87HSD DEPUY ORTHOPAEDICS, INC.:EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FO
87KWT; 87KSD DEPUY ORTHOPAEDICS, INC.:PATIENT WAS REVISED TO ADDRESS PAIN.
87KWY DEPUY INTERNATIONAL, LTD.:PT WAS REVISED TO ADDRESS DISLOCATION.
87KWY DEPUY ORTHOPAEDICS, INC.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87KWY; 87LZN; 87HRY; 87KWI; 87JDB DEPUY ORTHOPAEDICS, INC.:THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER
87KWZ DEPUY INTERNATIONAL, LTD.:THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR
87KWZ DEPUY ORTHOPAEDICS, INC.:DURING REVISION SURGERY REPORTED SEPARATELY, AFTER IMPACTING THE LINER, SURGEON NOTICED THE METAL RI
87KXA DEPUY INTERNATIONAL, LTD.:PT DEVELOPED A FEMORAL NECK FRACTURE 7 MONTHS POST OP.
87KXA DEPUY INTL, LTD.:PT WAS REVISED BECAUSE FEMORAL NECK COLLAPSED.
87KYJ DEPUY ORTHOPAEDICS, INC.:PATIENT WAS REVISED TO ADDRESS A FRACTURE OF THE DORSAL CORTEX OF PHALANGE WHICH OCCURRED DURING ORI
87LOD DEPUY CMW:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87LOD; 87MBB DEPUY CMW:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87LPH DEPUY INTERNATIONAL, LTD:PATIENT WAS REVISED TO ADDRESS FRACTURE OF THE STEM RESULTING IN LOOSENING AND METALLOSIS.
87LPH DEPUY INTERNATIONAL, LTD.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87LPH DEPUY INTL, LTD.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87LPH DEPUY INTL., LTD.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87LPH DEPUY ORTHOPAEDICS, INC.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87LPH DEPUY-CORK, A DIV OF DEPUY ORTHOPAEDICS:REVISION DUE TO LOOSENING OF THE STEM AND SLEEVE.
87LPH DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87LPH DEPUY-CORK, A DIVISION OF DEPUY ORTHOPEADICS:PT REVISED FOR LOOSE SLEEVE, FOUND IT TO BE UNDERSIZED WITH NO INGROWTH.
87LPH DEPUY-CORK/DIV OF DEPUY ORTHOPAEDICS, INC.:THE PT WAS REVISED BECAUSE OF DISLOCATION.
87LPH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, I:THE DEVICES ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER
87LPH & 87JDI DEPUY INTERNATIONAL, LTD.:EXAMINATION OF THE RETURNED DEVICES FINDS NOTHING OUTWARD TO SUGGEST PRODUCT ERROR. A COMPLAINT DATA
87LPH 87 JDI DEPUY ORTHOPAEDICS, INC.:PT WAS REVISED TO ADDRESS INFECTION.
87LPH 87JDI DEPUY INTERNATIONAL, LTD:PATIENT WAS REVISED FOR ALVAL.
87LPH 87JDI DEPUY INTERNATIONAL, LTD.:PT WAS REVISED TO ADDRESS PAIN.
87LPH 87JDI DEPUY ORTHOPAEDICS, INC.:PT WAS REVISED TO ADDRESS LOOSENING BECAUSE THE STEM WAS UNDERSIZED.
87LPH 87KWA DEPUY ORTHOPAEDICS, INC.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87LPH 87MEH DEPUY ORTHOPAEDICS, INC.:PATIENT WAS REVISED TO ADDRESS FEMORAL LOOSENING.
87LPH, JDI DEPUY INTL. , LTD.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87LPH, KWA DEPUY ORTHOPAEDICS, INC.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87LPH, LZO DEPUY ORTHOPAEDICS, INC.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87LPH, MEH DEPUY ORTHOPAEDICS, INC.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. IT IS STATED IN THE INITIAL PRODUCT INVES
87LPH; 87JDI DEPUY INTERNATIONAL, LTD.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87LPH; 87JDI DEPUY INTL LTD:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87LPH; 87JDI DEPUY ORTHOPAEDICS, INC.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87LPH; 87KWA; 87JDI; 87LZO DEPUY ORTHOPAEDICS, INC.:PT WAS REVISED TO ADDRESS INFECTION.
87LPH; 87MEH DEPUY ORTHOPAEDICS, INC.:THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER
87LPH;87MEH DEPUY ORTHOPAEDICS, INC.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87LPS DEPUY ORTHOPAEDICS, INC.:PT WAS REVISED TO ADDRESS CHRONIC DISLOCATION.
87LWJ DEPUY ORTHOPAEDICS, INC.:THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER
87LXH DEPUY FRANCE S.A.:EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO REVI
87LXH DEPUY INTERNATIONAL, LTD.:ASR HEAD AND TAPER WERE STUCK TOGETHER. DISTRACTOR BROKE AND IMPLANTS STILL COULD NOT BE SEPARATED.
87LXH DEPUY ORTHOPAEDICS, INC.:THE INSTRUMENT WAS BROKEN.
87LXH DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS:THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER
87LXH DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.:POST-OP X-RAYS REVEALED A PIECE OF UNK METAL IN THE PT. IT WAS DISCOVERED ON (B) (6) 2010 THAT THE P
87LXH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS:THE TARGETING DEVICE WAS DEFECTIVE. SURGERY WAS DELAYED BY MORE THAN 15 MINUTES.
87LXH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC.:EXAMINATION OF THE SUBMITTED INSTRUMENT COULD NOT REPLICATE THE REPORTED PROBLEM. THE PRODUCT WAS RE
87LXH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS:LAST FRIDAY DURING A KNEE SURGERY WITH HP INSTRUMENTS, THE INTRAMEDULLARY GUIDE (B) (4) BROKE INSIDE
87LXH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, I:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87LXT DEPUY ACE S.A. 'R.L.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87LXT DEPUY ORTHOPAEDICS, INC.:EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. THE INVESTIGATION WAS LIMITED TO RE
87LXT DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, I:THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAMINATION. THE PRODUCT CODE
87LZD DEPUY-CORK, A DIVISION DEPUY ORTHOPAEDICS, INC.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87LZO DEPUY INTERNATIONAL LTD:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87LZO DEPUY INTERNATIONAL, LTD:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87LZO DEPUY INTERNATIONAL, LTD.:PT WAS REVISED TO ADDRESS DISLOCATION.
87LZO DEPUY ORTHOPAEDICS, INC.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DUPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87LZO DEPUY-CORK, A DIV OF DEPUY ORTHOPAEDICS:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87LZO DEPUY-CORK, A DIV. OF DEPUY ORTHOPAEDICS:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87LZO DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87LZO 87MEH 87 KWA DEPUY FRANCE S.A.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87LZO, JDI DEPUY ORTHOPAEDICS, INC.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87LZO; 87JDI DEPUY ORTHOPAEDICS, INC.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87LZY DEPUY ORTHOPAEDICS, INC.:PATIENT REVISED FOR INFECTION.
87MBB 87LOD DEPUY CMW:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87MBB; 87LOD DEPUY CMW:PT WAS REVISED TO ADDRESS PAIN.
87MBF DEPUY ORTHOPAEDICS, INC.:EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE
87MBF, KWS DEPUY ORTHOPAEDICS, INC.:EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE
87MBF; 87KWS DEPUY ORTHOPAEDICS, INC.:PT WAS REVISED TO ADDRESS SHOULDER PAIN, WITH SUPERIOR MIGRATION.
87MBH A DIVISION OF DEPUY ORTHOPAEDICS:PT WAS REVISED TO ADDRESS CONTINUAL PAIN. THE PATELLA WAS FOUND TO BE SLIGHTLY LOOSE, BUT THE SURGEO
87MBH, 87JWH DEPUY ORTHOPAEDICS, INC.:PATIENT WAS REVISED TO ADDRESS INFECTION.
87MBH; 87JWH DEPUY ORTHOPAEDICS, INC.:THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAMINATION. A SEARCH OF THE
87MRA DEPUY INTL., LTD.:PT REVISED FOR PAIN. OBSERVED FLAT AREA ON CUP AND ON THE HEAD. THERE IS ALSO A CRACK ON THE CUP.
87MRA DEPUY ORTHOPAEDICS, INC.:THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER
87NDJ DEPUY ORTHOPAEDICS, INC.:PATIENT REVISED FOR DISLOCATION, FOUND CUP IN A VERTICAL POSITION.
87NDJ DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, I:PATIENT REVISED FOR FX PELVIS AND LOOSE CUP.
87NDJ 87LPH DEPUY ORTHOPAEDICS, INC.:PATIENT WAS REVISED TO ADDRESS FRACTURE OF THE ACETABULUM.
87NDJ 87LPH DEPUY RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, I:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87NDJ 87LPH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, I:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/
87NDJ, 87LPH DEPUY ORTHOPAEDICS, INC.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87NDJ, LPH DEPUY ORTHOPAEDICS, INC.:PATIENT REVISED TO ADDRESS INFECTION.
87NDJ, LPH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS:EXAMINATION OF THE RETURNED DEVICES FINDS EVIDENCE ON THE OUTER DOME OF THE LINER THAT A PROUD SCREW
87NDJ, LPH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, I:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHE
87NDJ/LPH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, I:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/
87NDJ; 87LPH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, I:PATIENT WAS REVISED TO ADDRESS DISASSOCIATION OF THE LINER FROM THE CUP.
87NDJ; 87LPH DEPUY-RAYNHAM/DIV OF DEPUY ORTHOPAEDICS, INC.:THE PT WAS REVISED BECAUSE OF INFECTION.
87NJL DEPUY (IRELAND):THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87NJL DEPUY CORK, A DIVISION OF DEPUY ORTHOPAEDICS:THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE CO
87NJL DEPUY INTERNATIONAL, LTD.:THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE CO
87NJL DEPUY INTL., LTD.:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87NJL DEPUY ORTHOPAEDICS, INC.:PATIENT REVISED FOR INFECTION IN BILATERAL KNEES.
87NJL DEPUY RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS:THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE CO
87NJL DEPUY RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, I:THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAMINATION. A SEARCH OF THE
87NJL DEPUY-COR, A DIVISION OF DEPUY ORTHOPAEDICS:NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. A SEARCH
87NJL DEPUY-CORK - A DIV OF DEPUY ORTHOPAEDICS, INC.:THE PRODUCT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. A S
87NJL DEPUY-CORK, A DIV OF DEPUY ORTHOPAEDICS:PT WAS REVISED TO ADDRESS FEMORAL LOOSENING. OSTEOLYSIS WAS DISCOVERED INTRAOPERATIVELY.
87NJL DEPUY-CORK, A DIV. OF DEPUY ORTHOPAEDICS:THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVEST
87NJL DEPUY-CORK, A DIVISION DEPUY ORTHOPAEDICS:PT WAS REVISED TO ADDRESS PAIN.
87NJL DEPUY-CORK, A DIVISION O F DEPUY ORTHOPAEDICS:THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OT
87NJL DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS:PT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL TRAY.
87NJL DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS, INC.:THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAMINATION. A SEARCH OF THE
87NJL DEPUY-CORK, A DIVISION OF DEPUY ORTHOPEDICS:THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OT
87NJL DEPUY-CORK, A DIVSIION OF DEPUY ORTHOPAEDICS:PT WAS REVISED TO ADDRESS INFECTION.
87NJL DEPUY-CORK, DIV OF DEPUY ORTHOPAEDICS:THE PRODUCT WAS NOT RETURNED FOR EXAM. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REP
87NJL DEPUY-CORK, DIV OF DEPUY ORTHOPAEDICS, INC.:PT WAS REVISED TO ADDRESS KNEE PAIN.
87NJL DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.:PT WAS REVISED TO ADDRESS INFECTION.
87NJL DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, I:PT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIA AT THE CEMENT/BONE INTERFACE. POLY WEAR WAS DISCOVE
87ZZZ DEPUY ORTHOPAEDICS, INC.:THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/
880.5100 INVACARE:MFR RECEIVED INFO THAT A USER REPORTEDLY FELL FROM AN INVACARE BED AND SUFFOCATED. INFO IS UNCLEAR A
880.5500 INVACARE:MFR RECEIVED A VOLUNTARY REPORT # (B) (4). THE REPORT CONTAINS INFO ALLEGING A SERIOUS INJURY. NO ID
880.6140 CHAMPION MFG.:THE CONSUMER STOOD ON THE PULL OUT STEP AND ALLEGEDLY FELL AND BROKE THEIR HIP.
890.3475 LIMB ORTHOSIS 3M COMPANY, CONSUMER HEALTH CARE:CONSUMER SAID, THERE WERE 2 KNEE BRACES, 1 SAID CONTAINS LATEX, THE OTHER SAID LATEX FREE. SHE SAID
890.3825 INVACARE:MANUFACTURER RECEIVED A SUMMONS ALLEGING A SERIOUS INJURY. THE SUMMONS DOES NOT CONTAIN A PRODUCT SE
890.3850 INVACARE:THE CONSUMER WAS ALLEGEDLY IN AN ACCIDENT INVOLVING A 9000XDT WHEELCHAIR. SERIOUS INJURY IS ALLEGED.
890.3860 INVACARE:THE CONSUMER WAS DRIVING ON A FLAT SURFACE OF A RAMP WHEN THE CHAIR ALLEGEDLY JERKED TO A SUDDEN STO
890.3920 INVACARE:INVACARE RECEIVED A SUMMON THAT AN ARM COMPONENT SOLD BY INVACARE WAS PART OF A CHAIR MANUFACTURED B
890.5050 INVACARE:THE CONSUMER HAD SURGERY ON HI LEG DUE TO A CAR ACCIDENT. THE CONSUMER WAS USING THE COMMODE IN THE
8F ANGIO-SEAL STS PLUS ST. JUDE MEDICAL:NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER W
8G STEREOTACTIC PROBE ETHICON:ABNORMAL MAMMOGRAM - MICROCALCIFICATIONS IN PRIOR BIOPSY CAVITY - SURGICAL CLIP PRESENT, 3MM FROM MI
8MM TROCAR COQ19 APPLIED:TROCAR NOT UNLOCKING.
95 DEGREES MODULAR PLATES SYNTHES ELMIRA:A 95 MODULAR PLATE, SPIRAL BLADE AND COUPLING SCREW WERE IMPLANTED TO TREAT AN INTRA-ARTICULAR RIGHT
A.V. FISTULA NEEDLE JMS SINGAPORE PTE. LTD:AS PER REVIEW WITH U.S. FDA INSPECTOR DURING THE INSPECTION, THIS SHALL BE AN MDR REPORTABLE EVENT A
A/C POWER CORD ELECTRI-CORD MFG. CO.:A GENERAL ELECTRIC -GE- PORTABLE XRAY UNIT'S POWER CORD SHORTED, WHILE THE TECHNICIAN WAS PLUGGING T
A/C POWERD HOSPITAL BED HILL-ROM RITTER:THE ACCOUNT ALLEGES THAT THE DEVICE WILL NOT GO INTO REVERSE TRENDELENBURG.
A/C POWERED ADJUSTABLE HOSP BED HILL-ROM RITTER:THE TECH REPLACED O'RINGS IN THE HEAD UP AND HEAD DOWN VALVES, THE HEAD HI/LOW UP AND DOWN VALVES, A
A/C POWERED ADJUSTABLE HOSPITAL HILL-ROM RITTER:THE TECH REPLACED THE LEFT AND RIGHT USER CONTROL MODULE CABLES, WHICH RESOLVED THE ISSUE. THE DEVIC
A/C POWERED ADJUSTABLE HOSPITAL BED HILL-ROM:TECHNICIAN ALLEGED THAT THE BED HAD NO FUNCTIONS.
A/C POWERED ADJUSTABLE HOSPITAL BED HILL-ROM RITTER:REPAIR UNK, HILL-ROM ATTEMPTED TO CONTACT THE ACCOUNT FOR RESOLUTION AND WAS UNSUCCESSFUL. PURSUANT
A/C POWERED ADJUSTABLE HOSPITAL BED (FNL) HILL-ROM:TECHNICIAN REPLACED THE POWER CONTROL MODULE AND THE LEFT CAREGIVER BOARD TO RESOLVE THE ISSUE. PURS
A/C POWERED ADJUSTABLE HOSPITAL BED (FNL) HILL-ROM RITTER:TECHNICIAN REPLACED THE POWER CONTROL MODULE TO RESOLVE THE ISSUE. PURSUANT TO OUR RESPONSE TO WARNI
A/C POWERED HOSP BED HILL-ROM RITTER:THE TECH REPLACED THE SIDECOM PENDANT, WHICH RESOLVED THE ISSUE. THE DEVICE OPERATES NORMALLY. PURSU
A/C POWERED HOSPITAL BED HILL-ROM:MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER, REQUESTING THEY CONTACT HILL-ROM. THE PURPOSE I
A/C POWERED HOSPITAL BED HILL-ROM PLUVIGNER:AS OF THIS REPORT, HILL-ROM HAS BEEN INFORMED THAT NO RESOLUTION HAS BEEN PERFORMED ON THIS DEVICE.
A/C POWERED HOSPITAL BED HILL-ROM RITTER:THE TECHNICIAN REPLACED THE POWER CORD PLUG, WHICH RESOLVED THE ISSUE. THE DEVICE OPERATES NORMALLY.
A/C POWERED HOSPITAL BED HILL-ROM, INC.:THE ACCOUNT ALLEGES THAT THE SIDERAIL WILL NOT FUNCTION DUE TO A BROKEN WELD, RESULTING IN AN INABIL
A/C POWERED HOSPITAL BED STRYKER CORP, MEDICAL DIV.:MS (B) (6) REPORTED THAT AN EMPLOYEE SUSTAINED A BACK STRAIN DURING THE WEEK OF JAN 30TH / 31ST. SHE
A/C POWERED HOSPITAL BED REMAN HILL-ROM RITTER:THE ACCOUNT ALLEGES THAT THE HI/LOW FUNCTION IS DRIFTING.
A/C POWERED HOSPITAL REMAN HILL-ROM RITTER:THE TECH REPLACED THE CONTROL BOARD, WHICH RESOLVED THE ISSUE. THE DEVICE OPERATES NORMALLY. PURSUAN
A/C POWERED HOSPTIAL BED HILL-ROM RITTER:THE ACCOUNT ALLEGES THAT THE HEAD SECTION HAS A SLOW DRIFT.
ABLATION CONTROL SYSTEM ST. JUDE MEDICAL:NONE OF THE COMPONENTS USED DURING THE PROCEDURE WERE RETURNED FOR EVALUATION. REVIEW OF THE DEVICE
ABLATION DIAGNOSTIC CATHETER MEDTRONIC, INC.:THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITION
ABLATION, CARDIAC, HIFU ST. JUDE MEDICAL:THE PATIENT HAD A SURGICAL CARDIAC ABLATION USING A ST. JUDE ULTRASONIC DEVICE. POST-OP, THE PATIENT
ABLATION, ENDOMETRIAL ETHICON INC.:MACHINE INDICATED IT WAS READY PRIOR TO ACHIEVING DESIRED TEMPERATURE. GREAT DEGREE IN TEMPERATURE F
ABLATION, ENDOMETRIAL ETHICON, INC.:GYNECARE MACHINE ALARMED AND DISPLAYED, 1 1/2 MINUTES INTO THE PROCEDURE, "HEATER FAILURE" CODE #650
ABLATION, ENDOMETRIAL GYNECARE WORLDWIDE:WHEN INITIALLY INSTILLING D5W, MACHINE APPEARED NOT TO RECOGNIZE THE CHANGE IN THE BALLOON PRESSURE.
ABLATION, ENDOMETRIAL HOLOGIC, INC.:WHILE IN USE, THE NOVASURE MACHINE NEVER COMPLETED THE ASSESSMENT. AFTER THREE TRIES A NEW HAND PIEC
ABLATION, ENDOMETRIAL, DEVICE GYNECARE WORLDWIDE:GYNECARE THERMA-CHOICE III WAS DEFECTIVE. THE BALLOON DID NOT INFLATE CORRECTLY. THE EQUIPMENT WAS
ABLATION, ENDOMETRIAL, DEVICE HOLOGIC, INC.:DURING UTERINE WALL ABLATION, THE DEVICE TIP WAS INSERTED INTO THE VAGINA, AND THE UMBRELLA LIKE SHE
ABSORABLE BARBED SUTURE NORTH HAVEN - USS:(B) (4). (B) (4).
ABSORBABLE BARBED SUTURE NORTH HAVEN - USS:.
ABSORBABLE BARBED SUTURE UNITED STATES SURGICAL:(B) (4).
ABSORBABLE BARBED SUTURE UNITED STATES SURGICAL A:PROCEDURE TYPE: ABDOMINOPLASTY OR PANNICULECTOMY. ACCORDING TO THE REPORTER: ALLEGEDLY, THE AREA OF
ABSORBABLE SURGICAL SUTURE NORTH HAVEN - USS:(B) (4). (B) (4).
ABSORBABLE SURGICAL SUTURE UNITED STATES SURGICAL A:(B) (4). (B) (4).
ABSORBABLE SURGICAL SUTURE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC:(B) (4)
ABSORBABLE SURGITIE GUT SUTURE DAVIS AND GECK CARIBE, LT:PROCEDURE TYPE: UNKNOWN. ACCORDING TO THE REPORTER: SURGEON SAYS AFTER THREE WEEKS, THE SUTURE DID N
ABSORBABLE SUTURE PRODUCT GOSPORT - USS:PROCEDURE TYPE: PROCTECTOMY. ACCORDING TO THE REPORTER: THE PT'S WOUND DEHISCED. THERE WAS A RE-OPER
ABSORBABLE SUTURE PRODUCT NORTH HAVEN - USS:PROCEDURE TYPE: UNKNOWN. ACCORDING TO THE REPORTER: THE AREAS WHERE THE SUTURE ARE TIED/KNOTTED (BOT
ABSORBABLE SUTURE PRODUCT UNITED STATES SURGICAL:PROCEDURE TYPE: APPENDECTOMY. ACCORDING TO THE REPORTER: THE SURGEON NOTICED THAT THE NEEDLE TIP WAS
ABSORBABLE SUTURING DEVICE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC:(B) (4)
ABSORBENT ANTIMICROBIAL WOUND DRESSING CONVATEC:REPORTED BY THE COMPLAINANT AS FOLLOWS.... ANEMIA WAS CAUSED AFTER APPLICATION OF AQAG. IT WAS OBSER
ABSORBER CARBON DIOXIDE PENLON LTD.:IT WAS REPORTED THAT A (B) (6) MAN DIED AFTER AN EMERGENCY CRANIECTOMY FOLLOWING A ROAD TRAFFIC ACCI
ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS SYBRON IMPLANT SOLUTIONS:ON (B) (6) 2009, A DOCTOR REPORTED TO (B) (6) THAT A PATIENT HAD AN ENDOPORE ABUTMENT THAT FRACTURED
ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS SYBRON IMPLANT SOLUTIONS GMBH:IT WAS REPORTED THAT A PATIENT HAD A FRACTURED ABUTMENT. THE PRODUCT WAS RETURNED TO (B) (4) FOR EVA
AC POWER HOSPITAL BED HILL-ROM RITTER:INFO RECEIVED INDICATES THE SERVICE REQUIRED LIGHT IS ON AND THERE ARE MULTIPLE 20-36 CODES ON THE B
AC POWER PLUG ELECTRI-CORD MFG. CO. MN OFFICE:(B) (4). FDA SAFETY INVESTIGATION OF CERTAIN MEDICAL DEVICE POWER CORDS MANUFACTURED BY ELECTRI-CORD
AC POWERD HOSPITAL BED HILL-ROM RITTER:INFO RECEIVED INDICATES THE CPR FUNCTION IS NOT WORKING WHEN PRESSED.
AC POWERED ADJUSTABLE HOSP BED HILL-ROM RITTER:CUSTOMER ALLEGED THAT HEAD UP FUNCTION DOESN'T WORK.
AC POWERED ADJUSTABLE HOSPITAL BED HILL-ROM RITTER:TECHNICIAN FOUND STIFFNER PLATE AND BUSHINGS WERE WORN. TECHNICIAN REPLACED STIFFNER PLATE AND BUSHI
AC POWERED HOPSITAL BED HILL-ROM RITTER:THE TECHNICIAN FOUND THE LOGIC BOARD LED'S ARE ALL SHOWING A HEAD, KNEE AND HI/LOW LOCKOUT ERROR. HE
AC POWERED HOSP BED HILL-ROM RITTER:THE TECHNICIAN REPLACED THE 22-POSITION CONNECTOR ON THE FOOTBOARD AND RETRACTING FRAME TO REPAIR TH
AC POWERED HOSPITAL HILL-ROM RITTER:INFORMATION RECEIVED INDICATES THE HEAD SECTION DOES NOT MOVE UP OR DOWN.
AC POWERED HOSPITAL BED HILL-ROM:THE TECH FOUND THE BRAKE MECHANISM WAS LETTING THE CABLE OVER THE ROLLERS. THE TECH REPLACED THE BRA
AC POWERED HOSPITAL BED HILL-ROM RITTER:THE TECH CLEANED THE HI/LOW DRIVE BRAKE ASSEMBLY TO REPAIR THE BED.
AC POWERED HOSPITAL BED HILL-ROM, INC.:THE TECHNICIAN REPLACED THE WORN STIFFENER PLATE AND BUSHINGS TO REPAIR THE BED.
AC POWERED HOSPITAL BED STRYKER CORP., MEDICAL DIV.:IT WAS REPORTED THAT THE BRAKES FORCE WAS NOT WORKING PROPERLY. NO ADVERSE CONSEQUENCE REPORTED.
AC POWERED HOSPTIAL BED HILL-ROM RITTER:THE ACCOUNT ALLEGES THAT THE SIDERAIL WILL NOT FUNCTION, DUE TO A BROKEN WELD, RESULTING IN AN INABI
AC POWERED PATIENT LIFT LIKO AB:(B) (4). THIS CASE WAS HANDLED AS A NORMAL REPAIR WHEN THE MOTOR WAS RETURNED TO OUR WORKSHOP IN 08/
AC-POWERED ADJUSTABLE HOSPITAL BED HILL-ROM:IT WAS REPORTED TO HILL-ROM THAT A CAREGIVER WAS UNDER THE EXCEL BED WHILE TRYING TO MOVE THE SIDERA
ACCELERATOR, LINEAR MEDICAL SIEMENS MEDICAL SOLUTIONS USA, INC.:PRELIMINARY RISK IS INDICATED: SEVERITY: THE COMPLAINT BEHAVIOR MAY POTENTIALLY RESULT IN A MINOR/ M
ACCELERATOR, LINEAR, MEDICAL SIEMENS MEDICAL SOLUTIONS USA, INC.:PRELIMINARY RISK ASSESSMENT INDICATES: SEVERITY: THE COMPLAINT BEHAVIOR MAY POTENTIALLY RESULT IN A
ACCELERATOR, LINEAR, MEDICAL VARIAN MEDICAL SYSTEMS:THE INVESTIGATION IN THE CIRCUMSTANCES LEADING UP TO THE WEDGE FALLING FROM THE MACHINE WAS COMPROMI
ACCESS NEEDLE MEDTRONIC SPINE LLC.:DEVICE NOT RETURNED, FOLLOW UP WITH COMPANY REPRESENTATIVE.
ACCESSORIES MEDTRONIC MINIMED:CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO
ACCESSORIES - NA ROCHE DIAGNOSTICS:CALLER REPORTS THE COAGUCHEK XS QUICK REFERENCE GUIDE IS INACCURATE. PATIENT TESTED >8.0 INR; THE CA
ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS ATTACHMENTS INTERNATIONAL:ON JANUARY 22, 2010, A DOCTOR REPORTED THAT THREE 1.6 SMOOTH STAPLE SCREWS BROKE OFF IN A PATIENT AN
ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS ATTACHMENTS INTL., INC.:ON JANUARY 13, 2010, A DOCTOR REPORTED TO ATTACHMENTS INTERNATIONAL, INC. THAT ON (B) (6) 2010 A PAT
ACCESSORY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION:IT WAS REPORTED THAT DURING IMPLANT, THE PHYSICIAN WAS USING A CPS DIRECT TO ACCESS THE CORONARY SIN
ACCESSORY KIT AMS:THE PT UNDERWENT AN ARTIFICIAL URINARY SPHINCTER PLACEMENT. POSTOPERATIVELY, THE PT DEVELOPED URINA
ACCESSORY PACK SHORT PORT BTT MAQUET PUERTO RICO, LLC:THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW 6 ACCESSORY
ACCESSORY TO OMP KCI USA, INC.:V.A.C. THERAPY WAS DISCONTINUED IN 2009 AFTER SUCCESSFULLY MEETING THE GOAL OF THERAPY. THE PIECE OF
ACCUCIRC KOL BIO-MED INSTRUMENTS, INC.:DR (B) (6) WAS USING AN ACCUCIRC ON A PT WITHOUT INCIDENT UNTIL THE HANDLE WAS DEPRESSED. HE WAITED
ACCUCIRC KOL BIO-MEDICAL INSTRUMENTS, INC.:DR WAS USING AN ACCUCIRC ON A PT WITHOUT INCIDENT UNTIL THE HANDLE WAS DEPRESSED. HE WAITED 5 MINUTE
ACCUTRAC PH MONITOR SIERRA SCIENTIFIC INSTRUMENTS:FOLLOWING 24 HOUR PH STUDY, STAFF WAS UNABLE TO UPLOAD PATIENT DATA. PH MONITOR SENT TO COMPANY FOR
ACETABULAR AUGMENT ZIMMER TMT:IT WAS REPORTED THAT THE PATIENT'S THA WAS REVISED BECAUSE THE SHELL CAME OUT OF THE PATIENT'S PELVI
ACETABULAR CUP / NXT SMITH & NEPHEW ORTHOPAEDICS LTD.:UPON REVIEWING THE REPORTED INFO, IT IS CLEAR THIS PT RECEIVED IMPLANTS FROM TWO DIFFERENT DEVICE MF
ACETABULAR CUP / NXT SMITH & NEPHEW ORTHOPAEDICS, LTD.:IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.
ACETABULAR CUP AND LINER / JDH SMITH & NEPHEW ORTHOPAEDICS, INC.:REVISION SURGERY WAS REPORTED DUE TO PAIN.
ACETABULAR CUP, FEMORAL HEAD, TAPER SLEEVE ADAPTOR DEPUY ORTHOPAEDICS, INC:PATIENT UNDERWENT A TOTAL HIP REPLACEMENT ONE YEAR AGO. SINCE SURGERY, PATIENT'S GAIT DETERIORATED A
ACETABULAR CUP/NXT SMITH & NEPHEW ORTHOPAEDICS LTD.:IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED, DUE TO INFECTION AND GREATER AND LESSER TROCHAN
ACID GENERATOR GUIDANT:PT EXPERIENCED AN EPISODE OF VENTRICULAR TACHYCARDIA AND THE PT'S AICD DID NOT ACTIVATE AUTOMATICALL
ACL FIXATION DEVICE CAYENNE MEDICAL:A CAYENNE MEDICAL APERFIX ACL FIXATION DEVICE WAS FOUND TO BE PROMINENT IN THE INTERCONDYLAR NOTCH A
ACMI EXTENDER CABLE AEH EC GYRUS ACMI:PT IN OPERATING ROOM FOR CYSTOSCOPY AND REMOVAL OF BLADDER STONE VIA ELECTROHYDRAULIC LITHOTRIPTOR.
ACTIFLO RECTAL CATHETER HOLLISTER, INC.:(B) (4). NO ADD'L INFO WAS PROVIDED. IT WAS REPORTED THAT THE ANCHOR STRAPS WERE LEFT UNSECURED CONT
ACUFIX ZIMMER SPINE:THE REPRESENTATIVE REPORTED THAT THE PT DID NOT FUSE. ADDITIONAL INFORMATION RECEIVED FROM THE SALES
ADAPTER, CARDIOPLEGIA, CORONARY SORIN GROUP USA INC:BEFORE OPENING THE PACKAGING, THE STERILE DISPOSABLE PIECE OF EQUIPMENT WAS VIEWED IN THE PACKAGING.
ADAPTOR, CARDIOPULMONARY BYPASS MEDTRONIC:WHILE MOVING PATIENT FOR BASIC NURSING CARE, ADAPTOR SNAPPED. PATIENT STARTED TO BLEED FROM CATHETER
ADHESIVE BANDAGE JOHNSON & JOHNSON INDUSTRIAL LTDA:CONSUMER STATED, SHE APPLIED 2 FABRIC BAND AIDS PER DAY FOR TWO DAYS TO A CUT ON HER RIGHT FINGER. S
ADHESIVE BANDAGES ASO LLC:PATIENT USED THE DEVICE ON A LOWER LEG WOUND. WHEN PULLING OFF THE DEVICE, HER SKIN WAS PULLED OFF W
ADHESIVE BANDAGES ITEM # 292839 ASO LLC:PATIENT'S PARENT REPORTED THAT A MARK -POTENTIAL SCAR- WAS LEFT ON THE CHILD'S ARM UPON USE OF THE D
ADHESIVE, TOPICAL SKIN ETHICON, INC.:(B) (4): CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPL
ADULT MULTI-LUMEN CATHETER PRODUCTS ARROW INTERNATIONAL INC:SAMPLE WILL NOT BE RETURNED FOR EVALUATION.
ADULT MULTI-LUMEN CATHETER PRODUCTS ARROW INTERNATIONAL INC.:(B) (4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.
ADULT MULTI-LUMEN CATHETER PRODUCTS ARROW INTL INC:IT WAS REPORTED THAT ON (B) (6) 2010, THE CATHETER WAS INSERTED VIA THE SUBCLAVIAN VEIN. WHEN THE TI
ADULT MULTI-LUMEN CATHETER PRODUCTS ARROW INTL INC.:(B) (4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
ADULT MULTI-LUMEN CATHETER PRODUCTS ARROW INTL., INC.:F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.
ADULT RESP PV CIRC HTD 6 FT CAREFUSION:THE HOME PT REPORTED THAT THE EXHALATION VALVES WERE "STICKING" AND THEREFORE, THE VENTILATOR STOPPE
ADULT UNIVERSAL BITE BLOCK B & B MEDICAL TECHNOLOGIES, INC./INTEGRA BIOTECHNI:MALE BURN PATIENT WAS VERY RESTLESS AND AGITATED AFTER DEBRIDEMENT SURGERY. THE PATIENT WAS TRYING T
ADULT VENTILATOR MAQUET CRITICAL CARE AB:PATIENT HAD BEEN ON MAQUET SERVO 300A VENTILATOR FOR TWO DAYS. VENT SETTINGS WERE 40% O2, PRESSURE
ADVANCED OPTICS ASPHERIC LENS BAUSCH & LOMB, INC.:THE BAUSCH & LOMB LENS INJECTOR WAS NOT FUNCTIONING PROPERLY. IT BENT THE HAPTICS ON THE LENSES. P
AED PHILIPS MEDICAL SYSTEMS:AED COULD NOT ANALYZE RHYTHM.
AED PHILIPS MEDICAL SYSTEMS, HEARTSTREAM:EVAL PENDING.
AED PHILIPS MEDICAL SYSTEMS, HEARTSTREAMS:MANUFACTURING DATE UNKNOWN. CONCLUSION USED AS ELECTRODES WERE NOT RETURNED WITH DEVICE. (DISCARDED
AED ZOLL WORLDWIDE:OUR HOSP HAD AN EMERGENCY "CODE BLUE." THE RESPONSE TEAM ARRIVED ON SCENE AND FOLLOWING ROUTINE PROC
AER EQUIPMENT MINNTECH CORPORATION:SHORTNESS OF BREATH, WHEEZING, ITCHING OF FACE AND NOSE, BLURRED VISION, RUNNY NOSE, AND INCREASED H
AFFIRM MULTIPLEX LASER CYNOSURE:FACIAL BURNS CAUSED BY LASER AFFIRM MULTIPLEX FROM CYNOSURE DUE TO MALFUNCTION OF THE TIP MP350, LAC
AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED BAXTER HEALTHCARE - HAYWARD:(B) (4). OCCASIONAL ASSOCIATIONS OF ABNORMALITIES IN HEMOSTASIS, WHICH APPEAR TO BE RELATED TO THE F
AGENT, TOOTH BONDING, RESIN KERR CORPORATION:THE DOCTOR REPORTED TWO INCIDENTS IN WHICH A CLASS V RESTORATION FAILED IN TWO PATIENTS SIX MONTHS A
AGGRESSIVE PLUS CUTTER 4MM STRYKER:DURING KNEE ARTHROSCOPY, SURGEON NOTED METAL SHAVINGS COMING FROM 4MM AGGRESSIVE CUTTER. SHAVINGS WE
AICD MEDTRONIC:PT EXPERIENCED CARDIOPULMONARY ARREST AND DURING CARDIOPULMONARY RESUSCITATION, THE R.N. REPORTED TH
AID, SURGICAL, VISCOELASTIC ALCON - BELGIUM/ S.A. ALCON-COUVREUR N.V.:THE DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS
AID, SURGICAL, VISCOELASTIC ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.:THE DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS
AID, SURGICAL, VISCOELASTIC ALCON - BELGIUM/S.A.ALCON-COUVREUR N.V.:A CLINICAL MANAGER REPORTED THREE PATIENTS EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) ONE DA
AID, SURGICAL, VISCOELASTIC ALCON-BELGIUM/ S.A.ALCON-COUVREUR N.V.:A CLINICAL MANAGER REPORTED THREE PTS EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) ONE DAY FOL
AIR LIFE TRI-FLO SUCTION CATHETERS CAREFUSION 211, INC.:(B) (6) PATIENT WITH TRACHEOSTOMY IS CARED FOR AT HOME BY THE PATIENT'S MOTHER. MOTHER HAD BEEN INST
AIRWAY EPITHELIAL CELL GENE EXPRESSION TEST FOR LU ALLEGRO DIAGNOSTICS:PT UNDERWENT BRONCHOSCOPY AS STANDARD OF CARE ON (B) (6) 2010. RESEARCH BRUSHINGS WERE COLLECTED FOR
AJ SYSTEM MEDRAD INTERVENTIONAL / POSSIS:EVENT CONSISTS OF PT DEATH DURING ANGIOJET THERAPY. THE PT IS A (B) (6) MALE. THE PT WAS LONG TERM D
ALARIS PUMP CARDINAL HEALTH:PRE-MATURE INFANT BORN (B)(6), WAS THE TWIN OF A FETAL DEMISE (B)(6). THE INFANT'S ADMISSION EXAM WA
ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL ZIMMER GMBH:(B) (4). CONCLUSION: THE INVESTIGATION SHOW, THAT THERE ARE NO SIGNS OF A MATERIAL OR PRODUCTION FAI
ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DU ZIMMER GMBH:(B) (4). CONCLUSION: NO PRODUCT WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS DI
ALPHA METASUL 28MM AND 32MM ACETABULAR ZIMMER GMBH:(B) (4). CONCLUSION: THE QUALITY RECORDS INDICATE THAT ALL THE SPECIFIED CHARACTERISTICS (MATERIAL,
ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS ZIMMER GMBH:CONCLUSION: THE QUALITY RECORDS INDICATE THAT ALL THE SPECIFIED CHARACTERISTICS (MATERIAL, MEASUREME
ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, ZIMMER GMBH:IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING AND PAIN. POSSIBLE ALLERGY OF THE PATI
AMATOMICAL SHOULDER WITH REMOVABLE HEAD ZIMMER GMBH:IT WAS REPORTED THAT THE SURGEON HAD PROBLEMS WITH ASSEMBLING DURING SURGERY.
AMBU SPUR II ADULT RESUSCITATOR AMBU A/S:NEWLY OPENED AMBU BAY EMPLOYED TO INTUBATED SPONTANEOUSLY BREATHING PT. DELIVERED O2 SO SATS ADEQUAT
AMBULANCE COT STRYKER CORP MEDICAL DIVISION:THE CUSTOMER HAS BEEN CONTACTED TO TRY TO OBTAIN FURTHER INFORMATION ABOUT THIS ALLEGED EVENT. IT IS
AMBULATORY CARE HILL-ROM RITTER:TECHNICIAN ALLEGED THAT THE BRAKE AT FOOT END OF BED WOULD NOT FUNCTION.
AMBULATORY INFUSION PUMP CURLIN MEDICAL LLC, MEDICAL SPECIALTIES DISTRIBUTO:THIS PT WAS RECEIVING 5 FLUOROURACIL VIA A CURLIN 4000 AMBULATORY INFUSION PUMP. IT WAS TO BE INFUSE
AMBULATORY INFUSION PUMP SMITHS MEDICAL MD (FORMERLY DELTEC, INC):RECEIVED NOTICE FROM THE FDA REGARDING AN INCIDENT. NO USER FACILITY INFO WAS INCLUDED WITH THE NOTI
AMBULATORY INFUSION PUMP SMITHS MEDICAL MD (FORMERLY DELTEC, INC.):AN EVENT DATE OF 2007, A REPORT DATE OF 11/05/2009, THE EVENT'S OUTCOME WAS REQUIRED INTERVENTION. T
AMS ARTIFICIAL SPHINCTER AMS:THE PT HAD A HISTORY OF URINARY INCONTINENCE AND A URINARY SPHINCTER THAT HAD BEEN WORKING REASONABL
ANAESTHESIA KIT, SPINAL SMITHS MEDICAL ASD, INC.:USER FACILITY REPORTED THAT THE USER WAS ATTEMPTING TO ADMINISTER SPINAL ANAESTHETIC FOR THE SECOND
ANAESTHETIC VAPORIZER DRAGER MEDICAL AG & CO. KG:THE INVESTIGATION HAS BEEN STARTED, RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.
ANALYZER, CHEMISTRY BECKMAN COULTER, INC:INCORRECT SODIUM RESULT RELEASED. A SODIUM RESULT WAS REPORTED AS HIGH AT 151. THE MD CALLED THE LAB
ANALYZER, CHEMISTRY SIEMENS HEALTHCARE DIAGNOSTICS:THERE WAS A PROBLEM WITH THE EXL1 CHEMISTRY ANALYZER GIVING LEVEL SENSE ERRORS. THE PREVIOUS LABORAT
ANATOMICAL PRESS-FIT HUMERAL STEM ZIMMER GMBH:IT IS REPORTED THAT THE PT WAS REVISED. REASON FOR REVISION IS UNK.
ANATOMICAL SHOULDER INSTRUMENT ZIMMER GMBH:IT IS REPORTED THAT ANATOMIC SHOULDER REVISED TO REVERSE SHOULDER. UPON PREPARATION OF THE HUMERAL C
ANATOMICAL SHOULDER INVERSE/REVERSE ZIMMER GMBH:IT IS REPORTED THAT AFTER FIRST WEEK POST-OP, PT HAD A FALL. BASEPLATE LOOSENED FROM GLENOID. THE BA
ANCHOR STRYKER ENDOSCOPY PUERTO RICO:ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETE.
ANESTHESIA DELIVERY UNIT GE HEALTHCARE:WE, AS A FACILITY, HAD 11 DATEX/OMEDA ADU-98 ANESTHESIA MACHINES SOFTWARE UPGRADE WHICH INCLUDE SOME
ANESTHESIA DELIVERY UNIT GE HEALTHCARE DATEX-OHMEDA:PATIENT WAS ASLEEP IN THE OR DURING A SURGICAL PROCEDURE. HOSPITAL EXPERIENCED POWER SURGE DUE TO A
ANESTHESIA MACHINE DRAEGER MEDICAL INC.:SURGICAL PROCEDURE BEING PERFORMED. ANESTHESIA MACHINE SET TO DELIVER 12% DESFLURANE AND ACCORDING T
ANESTHESIA MACHINE DRAEGER MEDICAL SYSTEMS, INC. (PNC):THE USER FACILITY HAS AT LEAST TWO TYPES OF DRAEGER ANESTHESIA MACHINES; THE NARKOMED MRI AND THE NA
ANESTHESIA MACHINE DRAGER MEDICAL:ON (B) (6) 2010, THIS WAS NOT THE FIRST CASE OF THE DAY IN THIS ROOM. MACHINE PASSED SELF-CHECK TEST
ANESTHESIA MACHINE DRAGER MEDICAL SYSTEMS, INC. (PNC):THE DEVICE WAS EVALUATED BY A DRAEGER SERVICE TECHNICIAN. THE DEVICE PERFORMED TO SPECIFICATION AND
ANESTHESIA PRODUCTS ARROW INTL., INC.:F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.
ANESTHESIA WORKPLACE DRAGER MEDICAL AG & CO. KG:THE DEVICE LOG AND BREATHING SYSTEM ARE REQUESTED FOR INVESTIGATION, BUT NOT YET RECEIVED. INVESTIGA
ANEURX MEDTRONIC:THE PATIENT PREVIOUSLY RECEIVED A MEDTRONIC ANEURX DEVICE (DATE UNKNOWN). FOLLOW UP REVEALED THAT TH
ANEURX MEDTRONIC VASCULAR:[(B) (4)] DEVICE MANUFACTURED BY MEDTRONIC.
ANEURYSM CLIP MIZUHO AMERICA, INC.:PT S/P ANEURYSM CLIPPING. LETHARGIC POSTOPERATIVELY, HOWEVER, APPEARED TO BE RECOVERING APPROPRIATEL
ANEURYSM CLIP MIZUHO IKAKOGYO CO.:CORRESPONDENCE WITH HOSP DID NOT ALLOW FOR AN IDENTIFICATION OF WHAT CLIP WAS ACTUALLY USED AT THE H
ANEURYSM CLIP MIZUHO IKAKOGYO CO. LTD.:PT WAS UNDERGOING A SURGICAL PROCEDURE THAT REQUIRED CLIPPING OF AN ANEURYSM. AFTER THE SURGERY, THE
ANGIO-SEAL DEVICE ST. JUDE MEDICAL:NO PRODUCT WAS RETURNED FOR EVAL AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE
ANGIO-SEAL DEVICE ST. JUDE MEDICAL, INC.:NO PRODUCT WAS RETURNED FOR EVALUATION AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINC
ANGIO-SEAL DEVICE ST. JUDE MEDICAL, PUERTO RICO, B.V.:NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING RE
ANGIO-SEAL EVOLUTION ST. JUDE MEDICAL:NO PRODUCT WAS RETURNED; THEREFORE, AN EVALUATION COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTO
ANGIO-SEAL EVOLUTION ST. JUDE MEDICAL, INC.:NO PRODUCT WAS RETURNED; THEREFORE, AN EVALUATION COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTO
ANGIO-SEAL STS PLUS ST. JUDE MEDICAL, INC.:NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING RE
ANGIO-SEAL VASCULAR CLOSURE DEVICE ST. JUDE MEDICAL:IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI), AN 8F ANGIO-SEAL STS PLUS
ANGIO-SEAL VASCULAR CLOSURE DEVICE ST. JUDE MEDICAL INC:ST JUDE MEDICAL WILL SUBMIT A F/U MEDWATCH UPON COMPLETION OF THE INVESTIGATION.
ANGIO-SEAL VASCULAR CLOSURE DEVICE ST. JUDE MEDICAL PUERTO RICO, B.V.:IT WAS REPORTED THAT AN ANGIO-SEAL WAS DEPLOYED POST DIAGNOSTIC HEART CATHETERIZATION, AND EVERYTHIN
ANGIO-SEAL VASCULAR CLOSURE DEVICE ST. JUDE MEDICAL, INC.:IT WAS REPORTED THAT AN ANGIO-SEAL WAS SELECTED FOR USE. THE PATIENT EXPERIENCED THROMBOSIS BY THE A
ANGIO-SEAL VASCULAR CLOSURE DEVICE ST. JUDE MEDICAL, PUERTO RICO, B.V.:NO PRODUCT WAS RETURNED; THEREFORE, AN EVAL COLD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECO
ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ST. JUDE MEDICAL:NO PRODUCT WAS RETURNED FOR EVALUATION AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINC
ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ST. JUDE MEDICAL, PUERTO RICO, B.V.:TWO FORMS OF IMAGING WERE RECEIVED WITH THE COMPLAINT. NO PRODUCT WAS RETURNED; THEREFORE, AN EVALUA
ANGIO-SEAL VIP ST. JUDE MEDICAL:NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING RE
ANGIO-SEAL VIP ST. JUDE MEDICAL PUERTO RICO, B.V.:IT WAS REPORTED FOLLOWING A CORONARY ANGIOGRAM A 6F ANGIO-SEAL VIP WAS DEPLOYED. TWO DAYS LATER AT H
ANGIO-SEAL VIP DEVICE ST. JUDE MEDICAL, INC.:NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER WAS
ANGIOGRAPHIC INJECTION SYSTEM ACIST MEDICAL SYSTEMS, INC.:THE EVENT INFO WAS PROVIDED TO ACIST'S MEDICAL ADVISORY BOARD FOR REVIEW. FOLLOWING IS THE MEDICAL A
ANGIOGRAPHIC INJECTOR MEDRAD, INC.:A MEDRAD SERVICE ENGINEER PERFORMED A SYSTEM CHECK-OUT ON THE AVANTA INJECTOR AND THE UNIT WAS FOUND
ANGIOGRAPHIC TUBING SET MEDRAD, INC.:THE DISPOSABLES WERE DISCARDED BY THE CUSTOMER AND THEREFORE COULD NOT BE EVALUATED BY MEDRAD. THE S
ANGIOPLASTY CATHETER COOK MEDICAL:PT WAS HAVING AN ANGIOPLASTY OF THE LEG. THE COOK CHECK FLO INTRODUCER, A 6 FRENCH, USED DURING THE
ANGLE RECON PL/LEFT/2.5MM THK SYNTHES BRANDYWINE:IMPLANT DATE REPORTED AS (B) (6) 2009. INVESTIGATION IS ONGOING, NO CONCLUSION CAN BE DRAWN. DEVICE
ANGLED INTERBODY TAP SPINE CRAFT, LLC:ANGLED INTERBODY TAP USED DURING SURGERY. TOP PORTION BROKE OFF AND WAS RETRIEVED BY PHYSICIAN.
ANNNULOPLASTY RING EDWARDS LIFESCIENCES:NO PRODUCT RETURN. THE RING WILL NOT BE RETURNED DUE TO IT WAS DISPOSED OF. THIS EVENT WAS DETERMINE
ANNULOPLASTY RING EDWARDS LIFESCIENCES:THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND S
ANNULOPLASTY RING SIZER EDWARDS LIFESCIENCES:THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND S
ANNUOPLASTY RING EDWARDS LIFESCIENCES:REPORTEDLY, THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 93.57 MONTHS DUE TO UNKNOWN REASON
ANTCER ZIMMER SPINE:EVENT DETAIL: PATIENT HAD FALLEN AND SAID HE COULD FEEL SOMETHING IN HIS NECK. THE SURGEON WANTED SO
ANTERIOR SPINAL FIXATION TRANS1:TRAINING RECORD OF SURGEON WAS CONFIRMED. GENERAL HISTORY OF SIMILAR DEVICES FROM CONTROLLED INVENTO
ANTIBIOTIC BONE CEMENT HOWMEDIA OSTEONICS:PATIENT SUFFERED A CARDIAC ARREST AFTER THE INJECTION OF THE BONE CEMENT DURING PLACEMENT OF HER PRO
ANTIMICROBIAL SUSCEPTIBILITY/IDENTIFICATION ANALYZ SIEMENS HEALTHCARE DIAGNOSTICS INC.:IDENTIFICATION "MIS-READS" BY THE ANALYZER DUE TO LIGHT SOURCE AND/OR DISPENSING OF KOVACS REAGENT.
ANTRUM RASP KARL STORZ ENDOSCOPY-AMERICA, INC.:PATIENT HAD A SEPTOPLASTY/PARTIAL TURBINECTOMY/BILATERAL ANTROSTOMY/REMOVAL OF CONCHA BULLOSA. IN O
AORTIC CATHETER EDWARDS LIFESCIENCES:CLASSIFICATION AS SERIOUS INJURY IS BASED SOLELY ON THE SWITCH TO CROSS CLAMP WHICH MAY REQUIRE AN A
AORTIC VALVED GRAFT ST. JUDE MEDICAL, PUERTO RICO, INC. (CS):IT WAS REPORTED THE PATIENT RECEIVED AN SJM AORTIC VALVED GRAFT. POSTOPERATIVELY, THE PATIENT HAD TO
APNEA MONITOR RESPIRONICS INC.:THE MFR WAS NOTIFIED BY A DURABLE MEDICAL EQUIPMENT SUPPLIER (DME) OF AN INFANT DEATH THAT OCCURRED
APPARATUS, NITRIC OXIDE DELIVERY DATEX-OHMEDA:THE INOVENT DELIVERY SYSTEM IS DESIGNED TO ALLOW DRUG TO FUNCTION INDEPENDENTLY FROM THE ELECTRONIC
APPARATUS, NITRIC OXIDE DELIVERY INO THERAPEUTICS LLC/IKARIA:THE PATIENT'S DESATURATION OCCURRED WHEN INOTHERAPY WAS STOPPED UNTIL A NEW INOMAX DS WAS PLACED ON
APPLIER, SURGICAL, CLIP ETHICON ENDO-SURGERY:DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE SURGEON INSERTED THE DEVICE INTO THE ABDOMEN, ATTEMPTING TO
APPLIERS, SURGICAL, CLIP ETHICON ENDO SURGERY, INC.:PATIENT UNDERGOING INGUINAL HERNIA REPAIR WHEN TWO SEPARATE ETHICON ENDOSCOPIC LIGAMAX CLIP APPLIERS
APPOSE ULC SINGLE USE SKIN STAPLER UNITED STATES SURGICAL:SURGEON WAS USING APPOSE ULC 35W STAPLES DURING A PROCEDURE WHEN IT WAS NOTED THAT THE STAPLES WERE
AQUEOUS SHUNT ALCON PRECISION DEVICE - SINKING SPRING:A FACILITY REPORTED THE SHUNT WAS SITTING TOO CLOSE TO THE IRIS, FOLLOWING INSERTION. THE SURGEON DE
AQUEOUS SHUNT OPTONOL, LTD.:THE DEVICE WAS NOT RETURNED FOR EVAL. THE DEVICE HISTORY RECORD REVIEW INDICATED THE PRODUCT MET REL
ARDIS ZIMMER SPINE:REQUESTS HAVE BEEN MADE FOR RETURN OF PRODUCT. EVALUATION IS PENDING UPON COMPLETED INVESTIGATION OF
ARGON BEAM COAGULATION - LAP PROBE CONMED ELECTROSURGERY:DURING A REMOVAL OF THE GALL BLADDER, A BURNING SMELL WAS NOTICED. THERE WAS A SMALL BURN TO THE INT
ARGON BEAM COAGULATION HANDPIECE CONMED ELECTROSURGERY:PROCEDURE: VAGINAL HYSTERECTOMY WITH ANTERIOR/POSTERIOR REPAIR AND INSERTION OF SUPRA-PUBIC CATHETER
ARGON BEAM COAGULATION, NOZZLE CONMED ELECTROSURGERY:CONMED ELECTROSURGERY HAS MADE SEVERAL ATTEMPTS TO CONTACT THE INITIAL REPORTER. WE HAVE HAD NO REPL
ARGON BEAM COAGULATOR CONMED:SPLENIC INJURY DURING SCHEDULED PROCEDURE. SURGEON CALLED FOR ARGON BEAM COAGULATOR TO STAUNCH BLEED
ARGON PLASMA COAGULATION ERBE ELECTROMEDIZIN GMBH:IT WAS REPORTED THAT AN ERBE SYSTEM; ARGON PLASMA COAGULATOR (APC) MODEL APC 2 WITH AN ELECTROSURGIC
ARGON PLASMA COAGULATOR ERBE ELECTROMEDIZIN GMBH:THE APC/ESU SYSTEM WAS THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON EACH U
ARGON PLASMA COAGULATOR ERBE ELEKTROMEDIZIN GMBH:IT WAS REPORTED THAT AN ERBE SYSTEM; ARGON PLASMA COAGULATOR (APC) MODEL APC 2 WITH AN ELECTROSURGIC
ARRAY CATHETER ST. JUDE MEDICAL:NO DEVICE WAS RETURNED FOR EVALUATION. THE ENSITE ARRAY CATHETER DEVICE HISTORY RECORD (DHR) REVIEW
ARROWG+ARD CATHETER PRODUCTS ARROW INTERNATIONAL INC:SAMPLE WILL NOT BE RETURNED FOR EVALUATION.
ARROWG+ARD CATHETER PRODUCTS ARROW INTL., INC.:(B) (4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
ARROWG+ARD CATHETER PRODUCTS. ARROW INTERNATIONAL INC:(B) (4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
ARROWGARD CATHETER PRODUCTS ARROW INTERNATIONAL INC:(B) (4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.
ARTERIAL BLOOD COLLECTION KIT UTAH MEDICAL PRODUCTS, INC.:AS THE RESPIRATORY THERAPIST WAS ATTEMPTING TO DRAW BACK BLOOD, BLOOD WAS NOTED TO BE COMING FROM A
ARTERIAL CANNULA EDWARDS LIFESCIENCES:PRODUCT HAS NOT YET BEEN RECEIVED, UNABLE TO EVALUATE AT THIS TIME.
ARTERIAL CATHETER PRODUCTS ARROW INTERNACIONAL INC.:(B) (4). SAMPLE WILL NOT BE RETURNED FOR EVAL.
ARTERIAL CATHETER PRODUCTS ARROW INTL., INC.:(B) (4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.
ARTERIAL EMBOLECTOMY CATHETER EDWARDS LIFESCIENCES:THE PATIENT WAS UNDERGOING SURGERY FOR REPAIR OF AN ARTERIOVENOUS (AV) FISTULA. DURING THE THROMBEC
ARTERIAL EMBOLIZATION DEVICE AGA MEDICAL CORPORATION:AGA MEDICAL CONTACTED THE IMPLANTING PHYSICIAN AND NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING
ARTERIAL GRAFT MEDTRONIC:ANEURX IMPLANTED IN 2004 FOR REPAIR OF ABDOMINAL AORTIC ANEURYSM. PT READMITTED IN 2009, DUE TO DETA
ARTERIAL SHEATH COOK MEDICAL:DURING THE PROCESS OF REMOVING THE ANSEL SHEATH AFTER AN ANGIOGRAPHY PROCEDURE, IT WAS IDENTIFIED TH
ARTERIAL, TRANSDUCER, BLOOD PRESSURE HOSPIRA:PATIENT TRANSFERRED BACK TO BED. THE ARTERIAL LINE WOULD NOT READ. ATTEMPTED TO ZERO THE LINE, AND
ARTHRO WAND ARTHROCARE CORPORATION:MINUTE PORTION OF ULTRAVAC 90 WITH INTEGRATED CABLE WAND WAS NOTED TO BE MISSING FROM THE HEAD OF TH
ARTHROSCOPE ARTHREX, INC.:THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS NOT CONFIRMED. THE PUMP
ARTHROSCOPE AND ACCESSORIES STRYKER INSTRUMENTS PUERTO RICO:DURING A THORACIC PERCUTANEOUS DISCECTOMY, THE TIP BROKE OFF AND REMAINED IN THE PT. A SMALL INCISIO
ARTHROSCOPE, ORTHOPEDIC CONMED LINVATEC:INVESTIGATION RESULTS: THIS DEVICE IS MADE OF STAINLESS STEEL AND IS NOT MEANT FOR IMPLANTATION. THE
ARTHROSCOPE, SHEATH KARL STORZ ENDOSCOPY-AMERICA, INC.:ADOLESCENT MALE WITH DISLOCATED THE PATELLA KNEE INJURY. MRI REVEALED MEDIAL RETINACULAR INJURY, INT
ARTHROSCOPIC CANNULA SMITH & NEPHEW INC., ENDOSCOPY DIVISION:DURING A RIGHT SHOULDER ARTHROSCOPY PROCEDURE, AN ARTHROSCOPIC TROCAR WAS BEING USED. WHEN IT WAS IN
ARTHROSCOPIC INSTRUMENT DEPUY MITEK:MITEK IS AT THIS POINT IN TIME IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOR
ARTHROSCOPY PUMP ARTHREX:THE CASE BEGAN IN USUAL MANNER. THE FIELD TURNED BLOOD TINGED. THE SURGEON INSTRUCTED THE SCRUB TO H
ARTHROSCOPY PUMP LINVATEC CORPORATION D/B/A CONMED LINVATEC:THE PATIENT IS AN ADULT WHO UNDERWENT ARTHROSCOPY OF THE LEFT KNEE. IT WAS DISCOVERED THE PATIENT HA
ARTHROSCOPY WAND AND SYSTEM STRYKER ENDOSCOPY:DURING THE PROCEDURE, THE PHYSICIAN WAS USING THE ABLATION MODE IN THE SUBACROMIAL SPACE; THE DEVICE
ARTHROSOCE AND ACCESSORIES STRYKER INSTRUMENTS PUERTO RICO:INVESTIGATION RESULTS INDICATE THAT THE PROBE BROKE NEAR THE PROXIMAL END AND THAT THE CANNULA WAS B
ARTICULATING ENDOPATHIC LINEAR CUTTER ETHICON ENDO SURGERY, INC, CORPORATE HEADQUARTERS:SURGEON PLACED ENDOSCOPIC LINEAR STAPLER ACROSS VESSEL/TISSUE TO STAPLE AND LIGATE. STAPLER JAWS WER
ARTIFICIAL BOWEL SPHINCTER AMERICAN MEDICAL SYSTEMS, INC.:ON (B) (6) 2009, THE BALLON WAS IMPLANTED IN A PATIENT. ON (B) (6) 2010 THE BALLOON WAS REMOVED AND
ARTIFICIAL DISC DEPUY SPINE, INC.:DEPUY SPINE BECAME AWARE OF AN ARTICLE THAT REVIEWED FOUR CASES OF CORNAL PLANE DEFORMITY AFTER 2-LE
ARTIFICIAL DISC JOHNSON & JOHNSON:I MUST TELL THAT THIS CHARITE DISC I GOT HAS DESTROYED MY YOUNG HEALTHY LIFE. ALL I WANTED / NEEDED
ARTIFICIAL DISC / MJO DEPUY SPINE, INC.:LITTLE INFORMATION IS KNOWN AND NO CONCLUSIONS CAN BE MADE.
ARTIFICIAL HIP ZIMMER:PT UNDERWENT BIPOLAR HEMIARTHROPLASTY/ENDOPROSTHESIS FOR RIGHT HIP FRACTURE, SUING ZIMMER BRAND VERS
ASPIRATION NEEDLE OLYMPUS:THE PT WAS HAVING AN OUTPATIENT ENDOSCOPY. THE VIZISHOT -SINGLE USE ASPIRATION NEEDLE- MALFUNCTIONED
ASPIRATION NEEDLE OLYMPUS AMERICA:THE WIRE STYLET BECAME STUCK HALF WAY IN THE VIZISHOR NEEDLE. THEY WERE UNABLE TO REMOVE. A NEW NEED
ATB PLATE SYNTHES (USA):STATUS POST ATB PLATE AND SCREW IMPLANTATION LEVEL L3-L4 PT RETURNED TO SURGEON'S OFFICE COMPLAINING
ATTACHMENT, MICRO DRILL TPS STRYKER INSTRUMENTS, INSTRUMENTS DIV.:AS THE SURGEON WAS OPERATING THE DRILL, HE NOTICED SMALL PIECES OF WHAT APPEARED TO BE DRIED TISSUE
AUDIBLE DILATING TROCAR CONMED CORPORATION:`AS THE OR PERSONNEL WENT TO USE THE TROCAR, THEY FOUND IT TO BE LEAKING AROUND THE SEAL. THE CD 19
AUTO STAPLER US SURGICAL:DURING THIS CASE, THE SURGEON BROKE FOUR PROTACK STAPLERS. THERE WAS NO PATIENT INJURY. THE SURGEON
AUTO SUTURE COVIDIEN:ON (B) (6) 2010, THE PT PRESENTED FOR EVAL OF ABDOMINAL PAIN. SHE IS STATUS POST LAP VENTRAL HERNIA
AUTO SUTURE TYCO HEALTHCARE GORUP:THERE WAS NO PT INJURY. THE PRODUCT FIRED ONE STAPLER AND THEN PROCEEDED TO JAM. THE MECHANISM LOCKS
AUTO SUTURE TYCO HEALTHCARE GROUP:THERE WAS NO PT INJURY. THE PRODUCT FIRED ONE STAPLER AND THEN PROCEEDED TO JAM. THE MECHANISM LOCKS
AUTOMATED BLOOD BANK ANALYZER IMMUCOR:THE ABO RH TYPING DISCREPANCY: THE ABO RH PERFORMED ON THE GALILEO DETERMINED THE ABO RH AS O POSITI
AUTOMATED BLOOD PRESSURE MONITOR MICROLIFE USA, INC.:AROUND 3:30 AM ON (B) (6) 2010, I WOKE UP WITH SOME CHEST PAIN. HAVING DECIDED TO MEASURE BLOOD PRES
AUTOMATED CHEMISTRY ANALYZER ABBOTT MANUFACTURING, INC.:(B) (4). AN ABBOTT FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO SERVICE THE A
AUTOMATED DISPENSING CABINET (ADC'S) CAREFUSION:(B) (4). ADDITIONAL DATA: PER CUSTOMER REPORT- CUSTOMER INDICATED THAT UPON INITIAL ATTEMPT TO LOGIN
AUTOMATED EXTERNAL DEFIB WELCH ALLYN PROTOCOL, INC:THE DEVICE WAS EVALUATED AND THE REPORTED MALFUNCTION WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WA
AUTOMATED EXTERNAL DEFIB WELCH ALLYN PROTOCOL, INC.:COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT, THE DEVICE FAILED TO DISCHARGE. COMPLA
AUTOMATED HEMATOLOGY ANALYZER ABBOTT DIAGNOSTICS DIVISION/CELLDYN:THE CUSTOMER REPORTED THAT THE NIGHT SHIFT OPERATOR GOT A DROP OF ENZYMATIC CLEANER ON HER EYELID WH
AUTOMATED IMMUNOASSAY ANALYZER ABBOTT MANUFACTURING, INC.:DURING INSTALLATION OF AN ARCHITECT ANALYZER AT THE CUSTOMER SITE, A FIELD SERVICE ENGINEER (FSE) AC
AUTOMATED MICROSCOPE FOR CYTOLOGY HOLOGIC, INC.:POSSIBLE INJURY - CUSTOMER HAS AN EMPLOYEE WITH CONCERNS REGARDING TOXICITY LEVELS OF RICHARD ALLAN
AUTOMATED URINE ANALYZER-JIL ROCHE DIAGNOSTICS:USER EXPERIENCED ISSUES WITH CONTROL AND PT RESULTS FOR URINE LEUKOCYTES. ONE PT URINE SAMPLE GENERA
AUTOSUTURE PROTACK 5MM UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC:THE 3RD, 4TH, AND 5TH PROTACK DEVICE USED DURING THE CASE WOULD NOT RELEASE TACKS WHEN FIRED. THE IN
AUTOVAC STRYKER ORTHOPEDICS:NURSE WENT TO EMPTY OUT THE AUTOVAC DRAIN WHICH WAS DRAINING OUT OF THE PATIENT'S KNEE AFTER SURGERY
AVAULTA ANTERIOR BIOSYNTHETIC SYST. TREVOUX - USS:BARD MDR REF #: 1018233-2009-00159. NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT #: FOR AN "AVAU
AVAULTA ANTERIOR BIOSYNTHETIC SYST. TREVOUX-USS:(B) (4). BARD MDR #: 1018233-2010-00002.
AVAULTA BIOSYNTHETIC POSTERIOR SYST TREVOUX - USS:(B) (4). BARD MDR REFERENCE#: 1018233-2010-00015. EXPLANT DATE: (B) (6) 2008.
AVAULTA MESH BARD:I HAD ANTERIOR AND POSTERIOR REPAIR USING AVAULTA MESH, SACROSPINOUS FIXATION, PERINEOPLASTY, AND TR
AVAULTA POSTERIOR BIOSYNTHETIC SYSTEM TREVOUX - USS:(B) (4). BARD MDR #: 1018233-2010-00003.
BACLOFEN PUMP MEDTRONIC:HUSBAND HAD CARDIAC ARREST DURING PHYSIOTHERAPY ABOUT 100 HOURS AFTER A MEDTRONIC SYNCHROMED SURGERY
BAG, DRAINAGE, CRRT GAMBRO RENAL PRODUCTS:PATIENT ON CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY)WITH NINE LITER EFFLUENT BAG IN USE. THE EFFLU
BALLOON CATHETER - PROFILER TIP ANGIO DYNAMICS:WHILE UNDERGOING LOWER EXTREMITY ANGIOGRAM WITH BALLOON ANGIOPLASTY, THE CATHETER BALLOON RUPTURED I
BALLOON EXPANDABLE STENT ATRIUM MEDICAL CORP.:PROCEDURES INCLUDED BILATERAL LOWER EXTREMITY ARTERIOGRAM AND ABDOMINAL AORTOGRAM, PROCEEDED WITH BI
BARD IMPLANTED PORT WITH OPEN-ENDED CATHETER CR BARD INC:IN 2009, A FEMALE, UNDERWENT UNEVENTFUL OUTPATIENT IMPLANTATION OF BARD PORT IMPLANTED PORT. FIVE DA
BARDEX ALL-SILICONE FOLEY CATHETER C.R. BARD, INC.:AFTER DEFLATING 8F INDWELLING CATHETER AND IN THE PROCESS OF REMOVING THE CATHETER, 1" OF THE CATHET
BARIATRIC BED SIZEWISE RENTALS, LLC:THE PATIENT WAS ON A VENTILATOR POST OP FROM A VENTRAL HERNIA REPAIR AND TREATMENT OF A WOUND INFECT
BARIATRIC BED STYKER MEDICAL:MALE PATIENT WEIGHING LESS THAN (B) (6) POUNDS WAS PLACED IN A BARIATRIC BED WITH ALL FOUR SIDE RAIL
BARIATRIC HOSPITAL BED BURKE, INC.:IT IS ALLEGED - A NURSE AND THREE OTHER PEOPLE WERE USING A SLIDER TO TRANSFER A PT FROM A RADIOLOGY
BARRIER MEMBRANE BIORA AB:REVIEW OF BATCH RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. THE INSTRUCTIONS FOR
BASIC-ONE PORTABLE FLUOROSCOPY TABLE MORGAN MEDESIGN:PORTABLE FLUOROSCOPY TABLE BROKE ALLOWING TABLE END TO FALL TO FLOOR. DATES OF USE: (B) (6) 2006 - (
BASKET, RETRIEVEL OLYMPUS AMERICA INC.:DURING ERCP, THE SURGEON SUCCESSFULLY PLACED THE LARGE GALLSTONE IN THE BASKET FOR RETRIEVAL. HOWEVE
BASKET, STONE RETRIEVAL BOSTON SCIENTIFIC:THE PT WAS UNDERGOING A LEFT URETEROSCOPY WITH STONE EXTRACTION. THE BASKET WAS INSERTED TO RETRIEVE
BAXA EM2400 COMPOUNDER BAXA CORPORATION:THE (B) (6) PHARMACY DEPARTMENT USES A BAXA EM2400 COMPOUNDER TO MAKE TPN'S AND OTHER ADMIXTURES. RE
BAXANO IO-FLEX MICROBLADE SHAVER BAXANO, INC.:ON (B) (6) 2010, THE PATIENT UNDERWENT A TRIPLE-LEVEL DECOMPRESSION USING THE BAXANO IO-FLEX SYSTEM.
BAXTER PUMP BAXTER:THE PT'S KCL RIDER BAG WAS EMPTY. AT CLOSER LOOK, IT APPEARS THAT THE RIDER SOMEHOW BACKED UP INTO T
BC DISTRACTOR BODIES (CENTER TRANSLATING) SYNTHES (USA):PATIENT IMPLANTED WITH 2 DISTRACTORS FOR PLANNED AP ADVANCEMENT OF THE MANDIBLE. AFTER 6 DAY LATENCY
BD MICROTAINER GENIE LANCET BECTON DICKINSON:A COMPLAINT HISTORY REVIEW WAS PERFORMED AND THIS IS THE FIRST REPORTED INCIDENT, RECORDED FOR THE I
BD POSIFLOW BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.:PATIENT CAME HOME FROM HOSPITAL WITH BD POSIFLOW ADAPTER AT THE END OF HIS PICC LINE. THE BLUE CAP H
BEAUTY PRODUCTS REMINGTON PRODUCTS CO.:DETAILS: PARAFFIN WAX TREATMENT SYSTEM BURNED CLAIMANT ON THE TOE AND HEEL, WHEN SHE TOUCHED TWO SID
BECLOFEN PUMP MEDTRONIC:HUSBAND HAD CARDIAC ARREST DURING PHYSIOTHERAPY ABOUT 100 HOURS AFTER A MEDTRONIC SYNCHROMED SURGERY
BED, HOSIPTAL HILL-ROM COMPANY INC.:WHEN USING THE BED CONTROLS TO MOVE THE BED, BOTH SIDERAILS WILL SHOW AN ALL MOTORS LOCKED (AML) CON
BED, HOSPITAL HILL ROM COMPANY, INC.:THE BED WAS FOUND TO BE LEAKING SOME TYPE OF FLUID. ENVIRONMENTAL SERVICES WAS PAGED, FLOOR WAS CLE
BED, HOSPITAL HILL-ROM:BRAKES ON BED MALFUNCTIONED AND BED MOVED WHILE PT WAS GETTING BACK TO BED. PT THEN ENDED UP SITTING
BED, HOSPITAL HILL-ROM COMPANY, INC.:BED WAS FOUND TO BE LEAKING SOME TYPE OF FLUID, FLOOR HAD SEVERAL VERY SLIPPERY AREAS. ENVIROMENTA
BED, HOSPITAL, BIRTHING HILL-ROM COMPANY, INC.:PATIENT'S HUSBAND WAS SITTING ON THE BOTTOM HALF OF THE LABOR BED, AND THE BED BROKE OUT FROM UNDER
BED, HOSPITAL, SPECIALTY KINETIC CONCEPTS INC (KCI):THE PATIENT WAS RECEIVING A BED BATH IN A KINAIR MEDSURG BED, AND WAS ROLLED ONTO HIS LEFT SIDE WITH
BEDSIDE COMMODE ALCO:PT WAS CUT ON FOREARM BY "TOILET PAPER" HOLDER ON BEDSIDE COMMODE. PT REQUIRED STITCHES TO CLOSE LAC
BEDSIDE MONITOR PHILIPS HEALTHCARE:THE PT WAS ADMITTED WITH ACUTE WHEEZE, ASTHMA, AND CONGENITAL CYANOTIC HEART DISEASE WITH A HISTORY
BERMAN ANGIOGRAPHIC CATHETER PRODUCTS ARROW INTL., INC.:IT WAS REPORTED PER MEDWATCH REPORT THAT THE INCIDENT INVOLVED A (B) (6) MALE PT. "ONE POINT FIVE CC
BGK 0/2.5 GAMBRO:PRISMASOL BAG DID NOT ALLOW FOR MIXING OF SODIUM BICARBONATE WITH OTHER COMPONENTS. BAG HAS VISIBLE
BHR ACETABULAR CUP WITH IMPACTOR SMITH & NEPHEW:ON (B) (6) 2008, I HAD A BIRMINGHAM HIP REPLACEMENT SMITH & NEPHEW BHR ACETABULAR CUP WITH IMPACTOR
BHR FEMORAL HEAD SMITH & NEPHEW:ON (B) (6) 2008, I HAD A BIRMINGHAM HIP REPLACEMENT SMITH & NEPHEW BHR ACETABULAR CUP WITH IMPACTOR
BI POLAR LINER AND SHELL/JDH SMITH & NEPHEW, INC., BROOKS MANUFACTURING SITE:IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISASSOCIATION.
BI-CAVAL AVALON LABORATORIES, LLC.:IT IS UNCLEAR FROM THE REPORT IF THE DAMAGE TO THE HEART OCCURRED AS A RESULT OF THE INITIAL INSERTI
BIFURCATED STENT GRAFT ENDOLOGIX, INC.:REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. RESULTS & CONCLUSIONS - USE
BILIARY CATHETER AND ACCESSORIES MERIT MEDICAL SYSTEMS, INC.:DEVICE EVALUATION - THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. CONCLUSIONS - A PRODUCT
BILIARY GUIDE WIRE WILSON-COOK MEDICAL:PT OF DR (B) (6) IN PROGRESS OF ERCP PROCEDURE. SHE USED A COOK GUIDE WIRE RR 18-480, IN WHICH IT BR
BILIARY STENT EV3:DEVICE WAS USED TO SUCCESSFULLY DEPLOY THE STENT. THE DISTAL END OF THE DELIVERY SYSTEM GOT CAUGHT I
BIO-ABSORBABLE IMPLANT ARTHREX, INC.:SCREW WOULD NOT DEPLOY. MANUFACTURER RESPONSE (AS PER REPORTER) FOR 2.5MM X 8MM MINI BIO- PUSH LOCK,
BIOCIDES SOLUTIONS ADVANCED STERILIZATION PRODUCTS:IT IS ALLEGED THAT DISOPA WAS RELATED TO REPORTS OF VARIOUS SYMPTOMS EXPERIENCED BY ELEVEN HEALTHCAR
BIOCIDES SOLUTIONS (LRJ) ADVANCED STERILIZATION PRODUCTS:A REPORT WAS RECEIVED THAT A HEALTHCARE WORKER (HCW) DEVELOPED PNEUMONIA-LIKE SYMPTOMS THAT LASTED A
BIOCIDES SOLUTIONS (MED) ADVANCED STERILIZATION PRODUCTS:(B) (4): COUGHING.
BIOCOMPARTMENTAL KNEE REPAIR SYSTEM CONFORMIS, INC.:PT WITH A BICOMPARTMENTAL KNEE IMPLANT WAS REVISED TO A TKA.
BIOLOGIC COMPONENT WRIGHT MEDICAL TECHNOLOGY, INC.:ALLEGEDLY WHEN THE INCISION WAS OPENED, IT WAS FOUND THAT THE BONE GRAFT WAS SOFT SO IT WAS REMOVED.
BIOLOGIC MATERIAL, DENTAL BIORA AB:SYMPTOMS AND TESTS/ADDITIONAL CLINICIAN VISITS WERE REPORTED TO THE TREATING CLINICIAN BY THE PT. IN
BIOLOX DELTA CERAMIC FEMORAL HEAD ZIMMER GMBH:IT IS REPORTED THAT THE DEVICES (HIP STEM, FEMORAL HEAD, ACETABULAR SHELL, AND ACETABULAR LINER) WER
BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODE ZIMMER GMBH:NO PRODUCT WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIAT
BIOMET LEFT TOTAL HIP COMPONENTS BIOMET, INC.:INFECTED LEFT TOTAL HIP ARTHROPLASTY. ORIGINAL TOTAL LEFT HIP REPLACEMENT SURGERY ON (B) (6)2009. DÉ
BIOPSY INSTRUMENT ANGIOTECH:THE BIOPSY GUN WAS PASSED THROUGH THE PATIENT'S SKIN ON THE FIRST ATTEMPT BUT NOT FIRED. A SECOND A
BIORESORBABLE ADHESION BARRIER GENZYME BIOSURGERY (SEPRAFILM/PACK):HIGHLY ELEVATED C REACTIVE PROTEIN RESULT [C-REACTIVE PROTEIN INCREASED]. CASE DESCRIPTION: A SPONTA
BIPOLAR ADAPTER GREATBATCH MEDICAL:RESULTS: REVIEW AND CONFIRMATION OF MANUFACTURING RECORDS WAS PERFORMED. NO ANOMALIES WERE FOUND. CO
BIPOLAR LEAD GREATBATCH MEDICAL:REVIEW AND CONFIRMATION OF MANUFACTURING RECORDS WAS PERFORMED. NO ANOMALIES WERE FOUND. DEVICE IS P
BIPOLAR PACING CATHETER KIT EDWARD LIFESCIENCES:THE PATIENT HAD A TEMPORARY PACEMAKER PLACED THROUGH THE JUGULAR VEIN. THE PACEMAKER WAS WORKING AS
BIPOLAR SCISSORS MAQUET CARDIOVASCULAR, LLC:THE DEVICE WAS RETURNED TO CARDIAC SURGERY IN 2010 FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE
BIRTH CONTROL DEVICE, PERMANENT CONCEPTUS, INC.:DURING A HYSTEROSCOPY PROCEDURE, THE FIRST ESSURE FROM THE KIT, WAS APPARENTLY DEFECTIVE WITH A BENT
BIRTHIND BED HILL-ROM RITTER:THE TECHNICIAN ADJUSTED THE SHAFT OF THE SHOCK, WHICH RESOLVED THE ISSUE. THE DEVICE OPERATES NORMAL
BIRTHING BED HILL-ROM:INFORMATION RECEIVED INDICATES THE BRAKE WILL ENGAGE, BUT DOES NOT HOLD.
BIRTHING BED HILL-ROM RITTER:ALLEGED THE BED HAS A HI/LOW DRIFT. HE HAS CLEANED THE DRIVE, BUT THERE IS STILL A SLIGHT DRIFT.
BISECTOR MAQUET CARDIOVASCULAR, LLC:THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE SCREW THREAD OF THE V
BIT, DRILL ARTHREX, INC.:IT WAS REPORTED THAT A DRILL BIT BROKE OFF IN THE MID-FOOT OF A PATIENT; THE BIT WAS NOT RETRIEVED.
BITEBLOCK ORIDION MEDICAL:SMART CAPNO FOUND TO BREAK APART. ON MULTIPLE OCCASION (AT LEAST THREE), PHYSICIANS OBSERVED THE THI
BIVENTRICULAR ICD BOSTON SCIENTIFIC:NOISE WAS OBSERVED ON THE RV CHANNEL OF THE ICD. AT EXPLANT, THE ICD HEADER WAS LOOSE AND THE RV LEA
BLADDER SLING ETHICON:I HAD THE GYNECARE TVT BLADDER SLING PUT IN ON (B) (6) 2010, HAD IMMEDIATE PAIN IN LEG GROIN WITH PR
BLOCKER INSERTER CUSTOM SPINE, INC.:PATIENT UNDERWENT SURGERY ON (B) (6) 2010 FOR COMPLETE L4 LAMINECTOMY, FACETECTOMIES, FOAMINTOMIES,
BLOM-SINGER VOICE PROSTHESIS IN-HEALTH TECHNOLOGIES:THE FLAPPER VALVE OF THE PROSTHESIS FELL OFF AFTER BEING INSERTED INTO THE PT. A SECOND ATTEMPT TO P
BLOOD ADMINISTRATION TUBING SET CARDINAL HEALTH 200, INC:NURSE WENT TO SPIKE UNIT OF BLOOD. TUBING FELL AWAY FROM SPIKE CHAMBER AFTER BAG WAS SPIKED. BLOOD
BLOOD COLLECTING TUBE ADAPTER SMITHS MEDICAL ASD, INC.:CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVAL. WHEN AND IF THE DEVICE
BLOOD COLLECTION RESERVOIR STRYKER INSTRUMENTS:THE DEVICE DRAINED PROPERLY FROM THE PATIENT FOR COLLECTION. THE DEVICE WOULD NOT FLOW FROM THE COL
BLOOD COLLECTION SET BECTON, DICKINSON & CO., (BD):PATIENT WAS STUCK MULTIPLE TIMES DUE TO CRACKED LUER LOCK ADAPTERS ON THE SAFETY COLLECTION DEVICE (
BLOOD COLLECTION SET SMITHS MEDICAL ASD, INC.:WHEN USING THIS DEVICE TO DRAW BLOOD SPECIMENS, AFTER THE 3RD OR 4TH TUBE THAT IS DRAWN, THE INNER N
BLOOD CONSERVATION SYSTEM STRYKER INSTRUMENTS, INSTRUMENTS DIV.:STAFF STATE THAT THERE IS NEW PACKAGING FOR THIS PRODUCT AND STERILITY IS COMPROMISED GETTING THE PR
BLOOD GLUCOSE LANCING DEVICE BAYER HEALTHCARE, LLC:LANCING DEVICES ARE NOT SERIALIZED OR ASSIGNED LOT NUMBERS, SO IT IS NOT POSSIBLE TO DETERMINE A MAN
BLOOD GLUCOSE METER BAYER HEALTHCARE LLC:THE ADVOCATE STATED THE CUSTOMER WAS RECEIVING ERRATIC BLOOD GLUCOSE READINGS WHEN TESTING WITH HER
BLOOD GLUCOSE METER BAYER HEALTHCARE, LLC:THE CUSTOMER ALLEGED THAT HE PERFORMED A CONTROL TEST AND RECEIVED A RESULT OF 338 MG/DL. HE DID NOT
BLOOD GLUCOSE MONITORING DEVICE NA:THE EVENT OCCURRED IN (B) (6).
BLOOD GLUCOSE MONITORING DEVICE ROCHE DIAGNOSTICS:CALLER REPORTED AN INCIDENT OF HYPOGLYCEMIA REQUIRING PROFESSIONAL MEDICAL TREATMENT AT A TIME WHEN
BLOOD GLUCOSE MONITORING DEVICE - CGA ROCHE DIAGNOSTICS:REPORTER ALLEGED HAVING HYPOGLYCEMIC SYMPTOMS WHEN SHE ATTEMPTED TO TEST HER BLOOD SUGAR WITH HER AD
BLOOD GLUCOSE MONITORING DEVICE - LFR ROCHE DIAGNOSTICS:REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 266 MG/DL, 463 MG/DL, 32
BLOOD GLUCOSE MONITORING DEVICE - NA ROCHE DIAGNOSTICS:THE EVENT OCCURRED IN ANOTHER COUNTRY.
BLOOD GLUCOSE MONITORING DEVICE - NBW ROCHE DIAGNOSTICS:CUSTOMER REPORTED AN INCIDENT OF HYPOGLYCEMIA REQUIRING PROFESSIONAL MEDICAL TREATMENT AT A TIME WHE
BLOOD GLUCOSE MONITORING TEST STRIPS ROCHE DIAGNOSTICS:CALLER REPORTED BLOOD GLUCOSE RESULTS 400 MG/DL AND 190 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM.
BLOOD GLUCOSE MONITORING TEST STRIPS - LFR ROCHE DIAGNOSTICS:CUSTOMER REPORTEDLY RECEIVED RESULTS OF 317 MG/DL AND 43 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM
BLOOD GLUCOSE MONITORING TEST STRIPS - LFR ROCHE DIAGNOSTICS CORP.:REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 42 MG/DL BACK TO BACK WITH A RESULT
BLOOD GLUCOSE MONITORING TEST STRIPS- LFR ROCHE DIAGNOSTICS:CUSTOMER REPORTEDLY RECEIVED RESULTS OF 27 MG/DL AND 89 MG/DL WITHIN 10 MINUTES ON THE COMPACT PLUS
BLOOD GLUCOSE MONITORING TEST STRIPS-LFR ROCHE DIAGNOSTICS:CALLER REPORTED BLOOD GLUCOSE RESULTS OF 323 MG/DL AND 135 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYST
BLOOD GLUCOSE MONTORING TEST STRIPS - LFR ROCHE DIAGNOSTICS:CALLER STATES CUSTOMER ADMINISTERED HUMALOG BASED ON RESULT OF 182 MG/DL OBTAINED ON THE ADVANTAGE S
BLOOD GLUCOSE TEST STRIPS BAYER HEALTHCARE LLC:THE ADVOCATE STATED THAT HER HUSBAND TESTED HIS BLOOD GLUCOSE AND RECEIVED A READING OF 284 MG/DL US
BLOOD GLUCOSE TEST STRIPS BAYER HEALTHCARE, LLC:THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 178 MG/DL FROM HIS CONTOUR AND A READING OF 96 MG/D
BLOOD GLUCOSE TEST SYSTEM APEX BIOTECHNOLOGY CORP.:CALLER INDICATED THE ASSURE 4 WAS READING HIGH. THE NURSE STATED THE FACILITY HAD ONE ISSUE WITH THE
BLOOD GLUCOSE TEST SYSTEM ARKRAY FACTORY, INC.:CALLER INDICATED THE RELION WAS READING HIGH STATING THAT MOST OF THE READINGS ON THE RELION METER W
BLOOD GLUCOSE TEST SYSTEM PARLEX (EUROPE), LTD.:PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED PRODUCT PERFORMED WITHIN SPECI
BLOOD GLUOCSE MONITORING DEVICE - NBW ROCHE DIAGNOSTICS:CALLER REPORTED MELTING OF THE BLACK PLASTIC THAT SURROUNDS THE ELECTRICAL CONTACT PINS OF THIS INFO
BLOOD TRANSFER DEVICE KENDALL:LUER FITTING AT BOTTOM OF ADAPTER'S BOWL WITH SYRINGE ATTACHED BROKE OFF LEAVING EXPOSED BUTT (NOT B
BLOODLINE NIPRO MEDICAL CORPORATION:.
BONE CEMENT BIOMET:PATIENT HAD BIOMET UNI KNEE REPLACEMENT IN (B) (6) 2007. RETURNED TO SURGERY FOR FAILED UNI KNEE, C
BONE CEMENT DEPUY CMW:EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE
BONE CEMENT DEPUY ORTHOPAEDICS, INC.:THE PT WAS REVISED BECAUSE OF LOOSENING OF THE FEMORAL COMPONENT IN THE CEMENT MANTLE. OSTEOLYSIS WA
BONE CEMENT DEPUY SPINE, INC.:THE AUTHOR IS THE TREATING PHYSICIAN AND HAS CONFIRMED THAT THE CASES IN WHICH THERE WAS LEAKAGE DID
BONE CEMENT STRYKER INSTRUMENTS KALAMAZOO:APPROXIMATELY 3 MONTHS POST OP FOR A VERTEBROPLASTY PROCEDURE, THE PT WAS EXPERIENCING PAIN. A CAT S
BONE DOWEL SPINAL GRAFT TECHNOLOGIES, LLC:DURING AN ANTERIOR/POSTERIOR L3-L4, L4-L5, L5-S1 FUSION UPON SEEDING A SECOND BONE DOWEL, THE DOWEL
BONE FIXATION PLATE ASCENSION ORTHOPEDICS, INC.:PT COMPLAINED THAT THE PLATE AND SCREWS WERE IRRITATING HER FOOT WHEN SHE HAD HER SHOE ON. SHE HAD A
BONE FIXATION PLATE (SCREW) ASCENSION ORTHOPEDICS, INC.:PT COMPLAINED THAT THE PLATE AND SCREWS WERE IRRITATING HER FOOT WHEN SHE HAD HER SHOE ON. SHE HAD A
BONE FIXATION PLATES AND BONE SCREWS BIOPLATE:A (B) (6), CONTAINING STERILE PRODUCT, WAS FOUND BY THE SURGEON TO BE UNSEALED. DEVICE WAS NOT USED.
BONE FIXATION PLATES AND SCREWS ORTHOHELIX SURGICAL DESIGN:THE SURGEON WAS PERFORMING A TMT FUSION. POST SURGERY 1 LOCKING SCREW BACKED OUT OF THE PLATE AND A
BONE FIXATION SCREW SYSTEM ORTHOHELIX SURGICAL DESIGN:WE REVIEWED PRODUCTS FROM OTHER LOTS OF THE SAME PART FAMILIES AND FOUND NOTHING OUT-OF-SPECIFICATIO
BONE GRAFT REPLACEMENT / NPM DEPUY SPINE, INC.:IT WAS REPORTED THAT A DMD PLACED HEALOS DENTAL IN A (B) (6) MALE FOR A BRIDGE. HE DID NOT USE ANY M
BONE GRAFT REPLACEMENT/LYC DEPUY SPINE, INC.:SALES REP REPORTED THAT ORAL SURGEON INFORMED HER THAT A PT HE HAD TREATED WITH HEALOS DENTAL HAD A
BONE HEALING SYSTEM / LPQ BROOKS MANUFACTURING SITE:APPROXIMATELY 3 MONTHS AGO, PATIENT UNDERWENT LEFT WRIST SURGERY AND TREATMENT WITH THE EXOGEN DEVIC
BONE MARROW ASPIRATION NEEDLE CARDINAL HEALTH:THE PHYSICIAN WAS ATTEMPTING TO PULL BIOPSY NEEDLE OUT AFTER BONE CORE SAMPLES WERE TAKEN AND THE BI
BONE PLATE BIOMET MICROFIXATION:CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF A
BONE PLATE SYNTHES ELMIRA:ADDITIONAL INFO HAS BEEN REQUESTED. MANUFACTURE DATE CANNOT BE DETERMINED WITHOUT A LOT NUMBER. INVE
BONE PLATE, BONE SCREW, BIODEGRADABLE INION OY:IN THIS CASE THE CAST HAD BEEN REMOVED TOO EARLY, I.E., ONLY 3 WEEKS POSTOPERATIVELY (VS TYPICAL BON
BONE SCREW BIOMET MICROFIXATION:REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. CURRE
BONE SCREW MEDTRONIC SOFAMOR DANEK:(B) (4): THREE DEVICES WERE REPORTED, AND IT IS UNK WHICH IS THE SUSPECT DEVICE. MULTI-AXIAL BONE SC
BONE SCREW WARSAW ORTHOPAEDIC INC.:IT WAS REPORTED THAT THE PT UNDERWENT AN OCCIPITOCERVICAL FUSION USING RIGID INTERNAL FIXATION. AT A
BONE SCREW WARSAW ORTHOPEDIC INC.:IT WAS REPORTED THAT A PT, WHO HAD POSTERIOR FIXATION SCREWS IMPLANTED FROM L4-S1 TWO MONTHS AGO, RE
BONE SCREW INSERTER AND BONE SCREW AMERICAN MEDICAL SYSTEMS, INC.:ON (B) (6) 2010, PATIENT REPORTED THAT SHE HAS EXPERIENCED NUMEROUS ISSUES FROM HER SCP INTEXEN MESH
BONE SCREWS DEPUY ORTHOPAEDICS, INC.:PT WAS REVISED TO ADDRESS INFECTION.
BOSTON SCIENTIFIC JAGWIRE BOSTON SCIENTIFIC:ERCP COMPLETED WITHOUT COMPLICATION, BUT NOTED SHREDDING OF THE COATING OF 2 GUIDEWIRES BY STONETOME
BOVIE VALLEY LAB:A PATIENT WAS IN SURGERY FOR A TOTAL HIP ARTHROPLASTY REVISION. AFTER SURGERY, WHEN UNDRESSING THE
BOVIE ELECTRODE TYCO VALLEYLAB:THE PT SUFFERED A 1 CM CIRCULAR FULL THICKNESS BURN ON THE ANTEROLATERAL ASPECT OF HIS RIGHT THIGH F
BOVIE PADS UNK:AFTER REMOVAL OF THE BOVIE PADS, IT WAS NOTED THE PATIENT SUSTAINED 2 DIME-SIZED BURNS TO THE LEFT U
BOVIE TIP VALLEYLAB:PT HAD SUPRA CERVICAL HYSTERECTOMY FOR MASSIVE FIBROIDS AND MENORRHAGIA. BOVIE TIP HAD COME OFF DURI
BRACHYTHERAPY APPLICATOR VARIAN MEDICAL SYSTEMS, INC:TESTING WAS CONDUCTED ON STOCK AND THE FIELD FAILURE WAS NOT REPRODUCIBLE UNDER NORMAL USE OR ROUGH
BRACHYTHERAPY TREATMENT PLANNING SOFTWARE VARIAN MEDICAL SYSTEMS, INC.:PATIENT UNDER TREATMENT FOR PROSTATE CANCER RECEIVED A RADIATION OVERDOSE. THE FIRST HALF OF THE TRE
BRACKET, METAL, ORTHODONTIC ORMCO CORPORATION:IN 2009, A DOCTOR REPORTED THAT A PATIENT EXPERIENCED ENAMEL LOSS WHEN ONE DAMON 3MX BRACKET DEBOND
BRAIDED POLYBLEND SUTURE ARTHREX INC.:PROCEDURE PERFORMED WAS LEFT TOTAL SHOULDER REPLACEMENT. AFTER FIXATION OF THE PROSTHESIS, THE SHOUL
BREAST BIOPSY DEVICE HOLOGIC, INC.:WHILE DOING A STEREOTACTIC BREAST BIOPSY, EVERY TIME THE RADIOLOGIST FIRED THE BIOPSY NEEDLE, THE CA
BREAST IMPLANT, GEL, SILICONE UNK:PATIENT HAD A LEAKING SILICONE GEL IMPLANT THAT HAD TO BE REMOVED DUE TO RUPTURE, (REMOVAL WITH CAPS
BREAST IMPLANT, SILICONE INAMED CORPORATION:PT DIAGNOSED AS HAVING BILATERAL RUPTURED SILICONE BREAST IMPLANTS. PT HAD SURGERY TO REMOVE THE RU
BREAST IMPLANT, SILICONE UNK:PATIENT HAVING BILATERAL BREAST SILICONE BREAST IMPLANT EXCHANGE FOR SALINE BREAST IMPLANTS FOR ASYM
BREAST IMPLANT, SILICONE GEL UNK:PATIENT HAD BILATERAL SILICONE GEL BREAST IMPLANT REMOVAL DUE TO RUPTURES.PATIENT TOLERATED THE PROC
BREAST IMPLANT, SILICONE, LEFT UNK:REMOVAL OF BILATERAL RUPTURED SILICONE IMPLANTS AND BILATERAL CAPSULECTOMIES.
BREAST IMPLANT, SILICONE, RIGHT UNK:REMOVAL OF BILATERAL RUPTURED SILICONE IMPLANTS AND BILATERAL CAPSULECTOMIES.
BREAST IMPLANTS UNK:REMOVE AND REPLACE BILATERAL BREAST IMPLANTS.
BREAST, IMPLANT, SILICONE INAMED CORPORATION:PATIENT PRESENTED WITH CONCERNS FOR BREAST ASYMMETRY AND RUPTURED SILICONE IMPLANTS. SHE HAD PREVIO
BREATHABLE CONTACT LENS CIBA VISION CORP.:I USED TO WEAR CIBA VISION NIGHT AND DAY CONTACT LENSES FOR NEARLY FIVE YEARS, LATE LAST YEAR, THE P
BRK NEEDLE ST. JUDE MEDICAL, AF DIVISION:IT WAS REPORTED THAT A PERICARDIAL EFFUSION WAS NOTED DURING A VT ABLATION PROCEDURE. THE EFFUSION C
BRONCHO CATH LEFT ES 37FR COVIDIEN/FORMERLY TYCO HEALTHCARE:THIS REPORT IS ASSOCIATED TO THE REPLACEMENT TUBE NOTED IN MFR# 2936999-2010-00116. THE CUSTOMER REP
BRONCHO CATH LEFT ES 39FR COVIDIEN, FORMERLY TYCOHEALTHCARE:THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE TUBE DEVELOPED A AIR LEAKAGE DURING PATI
BRONCHO-CATH LEFT W/CPAP SYSTEM COVIDIEN, FORMERLY TYCO HEALTHCARE:THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE CUFF WOULD NOT INFLATE DURING PATIENT US
BRONCHO-CATH LEFT W/CPAP SYSTEM COVIDIEN, FORMERLY TYCOHEALTHCARE:THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE CUFF WOULD NOT DEFLATE DURING PATIENT US
BRONCHOFIBERSCOPE OLYMPUS AMERICA, INC.:PATIENT UNDERWENT A BRONCHOSCOPY, BIOPSY, AND BILATERAL BRONCHOALVEOLAR LAVAGE WITH ROUTINE CULTURES
BRONCHOFIBERSCOPE OLYMPUS MEDICAL SYSTEM CORPORATION:OLYMPUS RECEIVED A MEDWATCH FORM STATING: "PT UNDERWENT A BRONCHOSCOPY, BIOPSY, AND BILATERAL BRONCH
BRONCHOFIBERSCOPE OLYMPUS MEDICAL SYSTEMS CORPORATION:OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADD'L INFO REGARDI
BRONCHOSCOPE OLYMPUS AMERICA, INC.:EMERGENT BRONCHOSCOPY NECESSARY DURING PERCUTANEOUS TRACH PROCEDURE. BRONCHOSCOPE UNABLE TO FOCUS A
BRONCHOSCOPE, PEDIATRIC OLYMPUS AMERICA, INC:PEDIATRIC FLEXIBLE BRONCHOSCOPES (BOTH OLYMPUS, MODEL # BFXP160F), DURING PRE-USE AND CLEANING INSPE
BRONCHOSCOPE, PEDIATRIC OLYMPUS AMERICA, INC.:PEDIATRIC FLEXIBLE BRONCHOSCOPES (BOTH OLYMPUS, MODEL # BFXP160F), DURING PRE-USE AND CLEANING INSPE
BTO - TUBE, TRACHEOSTOMY (W/WO CONNECTOR) SMITHS MEDICAL INTERNATIONAL LTD.:DEVICE EVAL: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MFR WILL FILE A F/U REPORT DETAILING THE R
BTR - TRACHEAL TUBES SMITHS MEDICAL INTERNATIONAL LTD:A REPORT WAS RECEIVED THAT ALLEGES THAT THE ENDOTRACHEAL TUBE WAS IN SITU FOR 10 DAYS WHEN THE PATIE
BURCH/SCHNEIDER REINFORCEMENT CAGE ZIMMER GMBH:IT WAS REPORTED THAT THE CUP WAS BROKEN.
BUTTERFLY NEEDLE, 23G X 3/4" GREINER BIO-ONE GMBH:ACCIDENTAL NEEDLE-STICK CAUSED BY UNSAFE 23G X 3/4" BUTTERFLY NEEDLE. THE NEEDLE IS MFG BY GREINER B
BUTTON SWITCH PENCIL WITH 10 FT. CORD (WITH HOLSTE MEGADYNE MEDICAL PRODUCTS:ON (B) (6) 2010, REUSABLE CAUTERY USED IN CASE. AT THE END OF THE PROCEDURE DRAPES WERE REMOVED, 1/2
C-ARM GE OEC MEDICAL SYSTEMS (SLC):CUSTOMER REPORTED C-ARM IS MAKING A LOUD SNAPPING OR POPPING SOUND IN THE MIDDLE OF PT (PAIN MANAGEM
CADD CASSETTE SMITHS MEDICAL:LEAKING CASSETTE.
CADD CASSETTE SMITHS MEDICAL, INC.:BUBBLES IN CASSETTES.
CADD CASSETTES SMITH'S MEDICAL:CREASES IN CASSETTES.
CADD CASSETTES SMITH'S MEDICAL, INC.:CREASES IN CASSETTES.
CADD MEDICATION CASSETTE RESERVOIR SMITHS MEDICAL MD, INC.:SMITHS CADD MEDICATION CASSETTE RESERVOIR -REF 21-7002-24; LOT 2015-01; 010X10-, A LONG HUMAN HAIR W
CADD SOLIS SMITH MEDICAL:PT WITH HISTORY OF ADENOCARCINOMA OF THE RIGHT LOBE OF THE LUNG, ADMITTED WITH SEVERE LEFT-SIDED CHE
CAGE MEDTRONIC SOFAMOR DANEK USA, INC.:(B) (4). LITERATURE ARTICLE CITATION: RAJ K SHAH ET AL. RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN
CAGE SOFAMOR DANEK DEGGENDORF GMBH:(B) (4). NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WAS RETURNED TO THE MFR FOR EVAL. WE
CALAXO / HWC MANSFIELD MANUFACTURING SITE:LETTER RECEIVED INDICATES PATIENT REQUIRED CORRECTIVE SURGERY TO REMOVE THE CALAXO SCREWS DUE TO DEF
CALAXO SCREW / HWC MANSFIELD MANUFACTURING SITE:PATIENT HAD CALAXO SURGERY (B) (6) 2006; REVISION ACL RECONSTRUCTION AND DEVELOPED KNEE PAIN AND SWE
CALAXO SCREW, 7MM X 25MM, STERILE / HWC MANSFIELD MANUFACTURING SITE:PT RECEIVED ACI RECONSTRUCTION DOUBLE BUNDLE WITH TIBIALIS ANTERIOR ALLOGRAFT USING A CALAXO SCREW O
CALDERA SLING CALDERA MEDICAL:CALDERA T SLING USED FOR BLADDER REPAIR ON (B) (6) 2009. NO ISSUES OR PROBLEMS DURING SURGERY OR DUR
CALIBRATED PASSING PIN W/ DRILL TIP (BEATH PIN) DEPUY MITEK, A JOHNSON & JOHNSON COMPANY:DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) RECONSTRUCTION, THE BEATH PIN (GUIDE PIN) BROKE, LEAVING
CANCELLOUS BONE SCREWS SYNTHES MONUMENT:ADDITIONAL INFO HAS BEEN REQUESTED. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DE
CANCELLOUS SCREW WARSAW ORTHOPEDIC INC.:IT WAS REPORTED THAT A PATIENT UNDERWENT A C5-C6-C7 ACDF USING THE CERVICAL PLATING SYSTEM. APPROXIM
CANNULA MAQUET CARDIOVASCULAR, LLC:THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW 7XS C-RING AND S
CANNULA, AIR INJECTION BAUSCH & LOMB, STORZ OPTHALMICS:A 30 GAUGE IRRIGATING CANNULA BROKE IN TWO PIECES. BOTH PIECES WERE FOUND BEFORE THE END OF THE CASE
CANNULA, ARTERIAL, CARDIOPULMONARY MEDTRONIC PERFUSION SYSTEMS:DURING DECANNULATION, THE AORTIC CANNULA WAS NOTED TO HAVE BROKEN OFF AT THE TIP WITH THE WIRE EXPOS
CANNULA, CARDIOPLEGIA MEDTRONIC PERFUSION SYSTEMS:PHYSICIAN PLACED THE GUNDRY RETROGRADE CARDIOPLEGIA CANNULA INTO THE RIGHT CORONARY SINUS OF THE PAT
CANNULA, VENOUS, CARDIOPLUMONARY MEDTRONIC PERFUSION SYSTEMS:PATIENT BECAME UNSTABLE AFTER CARDIAC SURGERY REPAIR. PATIENT WENT ON CARDIOPULMONARY BYPASS (CPB)
CANNULA,CARDIOPULMONARY, PEDIATRIC AORTIC MEDTRONIC PERFUSION SYSTEMS:TOWARD THE END OF THE BYPASS RUN, THE CARDIOPLEGIA CANNULA WAS BEING REMOVED BY A NURSE PRACTITIONER
CANNULATED LDA SCREWS OSTEOMED L.P.:PT'S SECOND TOE WAS LONGER THAN THE GREAT TOE. DURING THE REOPERATION FOR PAIN, THE DOCTOR DECIDED T
CANNULATED SCREW SMITH/NEPHEW:IN 2008, RIGHT ANKLE SURGERY PERFORMED POST TRAUMATIC DEGENERATIVE CHANGES AND PREVIOUS SURGERIES IN
CANNULATED SCREWS SYNTHES (USA):(B) (6) PT WITH LEFT SLIPPED CAPITAL FEMORAL EPIPHYSIS (SCFE) MILD HAD PERCUTANEOUS SCREW FIXATION O
CANNULATED SCREWS, LONG THREAD SYNTHES (USA):SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A LOT NUMBER. INVEST
CAPSULE ENDOSCOPY GIVEN IMAGING PILLCAM:PT WAS GIVEN CAPSULE FOR PILLCOM CAPSULE ENDOSCOPY. EQUIPMENT WAS REMOVED AND CONNECTED TO COMPUTER
CAR 27 NITI SURGICAL SOLUTIONS:DURING SURGICAL CONNECTION OF TWO ENDS OF COLON, A PRODUCT CALLED THE COLONRING WAS UTILIZED TO MAIN
CARBON DIOXIDE SURGICAL LASER LUMENIS, LTD YOKNEAM:AN EVALUATION OF THE REPORTED EVENT BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT CONCLUDED THE TREATME
CARBON DIOXIDE SURGICAL LASER LUMENIS, LTD. YOKNEAM:AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL SPECIALIST CONCLUDED THAT THE DEVICE OPE
CARBON DIOXIDE SURGICAL LASER FIBER DELIVERY DEVIC LUMENIS LTD.:AN EVALUATION OF THE EVENT DETAILS BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT CONCLUDED THE ROOT CAU
CARDIAC ABLATION PERCUTANEOUS CATHETER BOSTON SCIENTIFIC - SAN JOSE:SALES REPRESENTATIVE REPORTED "POSSIBILITY THAT A BLAZER 8F 8MM WAS USED IN AN A-FIB ABLATION. 4 DAY
CARDIAC DEFIBRILLATOR BOSTON SCIENTIFIC CORP.:IN 2009, PT ADMITTED FOR ICD SHOCKS AND POSSIBLE RIGHT VENTRICULAR LEAD, WORKED UP AND TRANSFERRED E
CARDIAC ELECTROPHYSIOLOGY MAPPING SYSTEM, 3D ST. JUDE MEDICAL:THE MAPPING SYSTEM WAS NOT CORRELATING THE LOCATION OF THE ABLATION CATHETER CORRECTLY. IT WAS DISPL
CARDIAC MARKER TEST BIOSITE INCORPORATED:CUSTOMER RECEIVED A FALSE POSITIVE TROPONIN (TNI) RESULT. PATIENT WAS ADMITTED TO THE HOSPITAL.
CARDIAC OCCLUSION DEVICE AGA MEDICAL CORPORATION:THE AMPLATZER SEPTAL OCCLUDER WAS RECEIVED AT AGA MEDICAL IN ITS ORIGINAL CONFIGURATION. THE DEVICE
CARDIAC PACEMAKER ELA MEDICAL, S.A.S.:PATIENT REPORTED THAT HE WAS ELECTROCUTED WHILE WORKING. UPON INTERROGATION, THE DEVICE WAS NOT PACI
CARDIAC PACEMAKER SORIN BIOMEDICA CRM S.R.L.:THE ATRIAL OSCOR LEAD WAS RETURNED TO OSCOR FOR ANALYSIS. THE ANALYSIS IS PENDING. DEVICE WAS NOT RE
CARDIAC PACEMAKER SORIN CRM S.A.S.:THE ANALYSIS ON THIS DEVICE IS PENDING.
CARDIAC PERCUTANEOUS ABLATION CATHETER IRVINE BIOMEDICAL, A ST JUDE MEDICAL COMPANY:THE CATHETER WAS DISCARDED AFTER THE PROCEDURE. THE LOT NUMBER WAS NOT AVAILABLE TO REVIEW THE DEVIC
CARDIOLOGY GUIDING CATHETERS (DQY) CORDIS DE MEXICO:ADD'L INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.
CARDIOLOGY VASCULAR ACCESS (DRE) CORDIS DE MEXICO:THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED
CARDIOTOMY RESERVOIR MEDTRONIC PERFUSION SYSTEMS:DURING ROBOTIC ASSISTED MINIMALLY INVASIVE DIRECT CORONARY ARTERY BYPASS (MIDCAB) SURGERY A LOUD, HI
CARDIOTOMY RESERVOIR, CARDIOPULMONARY MEDTRONIC PERFUSION SYSTEMS:PREPARING TO INITIATE CARDIO PULMONARY BYPASS. SURGEONS CANNULATING AT THE FIELD, WHILE PUMP SUCKERS
CARDIOVASCULAR PRODUCTS ABBOTT VASCULAR:CARDIAC CATH LAB TEAM WAS CALLED IN FOR AN EMERGENCY CARDIAC ARREST PT. PT WAS CRITICALLY ILL-VENTED
CARDIOVASCULAR SURGICAL INSTRUMENT CARDICA, INC.:THE PAS-PORT DEVICE WAS UNLIKELY TO BE THE CAUSE OF THE EVENT. THE OBSERVED PSEUDOANEURYSM WAS LIKEL
CARDIOVERTER-DEFIBRILLATOR LEAD MEDTRONIC:FRACTURE OF RT VENTRICULAR IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR LEAD WITH ELEVATED PACING THRESHOL
CARDIVA CATALYST DEVICE CARDIVA MED, INC.:INTERVENTIONAL CARDIOLOGIST WAS DEPLOYING THE INVOLVED ARTERIAL CLOSURE DEVICE. IT SEEMED TO DELIVER
CARDIVA CATALYST DEVICE CARDIVA MEDICAL INC.:DOCTOR WAS USING THE ARTERIAL CLOSURE DEVICE, AND IT SEEMED TO DELIVER OK, BUT THEN HE GOT OOZING AR
CARDIVA CATALYST DEVICE CARDIVA MEDICAL, INC.:THE PT WAS RECOVERING POST-ANGIOGRAM WITH STENT PLACEMENT. SHE HAD A CARDIVA CATALYST DEVICE IN PLAC
CAROTID BYPASS SHUNT BARD PERIPHERAL VASCULAR, INC.:IT WAS REPORTED THAT DURING AN OPEN CAROTID ENDARTECTOMY PROCEDURE, THE CLAMPS USED TO HOLD THE SHUN
CAROTID STENT ABBOTT VASCULAR:STENT WAS TO BE PLACED IN THE LEFT COMMON CAROTID ARTERY BY A CARDIOLOGIST IN THE CATH LAB. AFTER PL
CARRIER, SKIN GRAFT ZIMMER:THE MESH CARRIER THAT THE SKIN GRAFT IS PLACED ON AND THEN PLACED THROUGH THE MESHING DEVICE CAUSED
CARTO 3D CARDIAC MAPPING SYSTEM RMT BIOSENSE WEBSTER:IN THE ELECTROPHYSIOLOGY LAB THE PT WAS BEING TREATED FOR ATRIAL FLUTTER, RIGHT SIDE. DURING THE CAR
CATH INDURA MEDTRONIC:PATIENT HAD OUTPATIENT INSERTION OF INTRATHECAL PUMP AND CATHETER ON (B) (6) 2010. HE WAS OBSERVED P
CATHETER MEDTRONIC NEUROMODULATION:PAIN PUMP WAS NOT WORKING. CATHETER WAS BROKEN.
CATHETER STABILIZATION DEVICE KIMBERLY CLARK HEALTHCARE:TUBE FEEDING HOOKED UP TO INCORRECT PORT AND INFUSION INITIATED. SUGGEST PORTS BE LABELED ON TWO SID
CATHETER, 57CM MEDTRONIC, INC:MEDTRONIC PUMP PORT ACCESSED BY RN FOR REFILL USING MEDTRONIC REFILL KIT. UNABLE TO ASPIRATE; RESIST
CATHETER, ABLATION, CARDIAC, HIFU ST. JUDE MEDICAL:DURING A MAZE PROCEDURE, THE EPICOR ULTRACINCH WAS FOUND TO HAVE 2 CELLS THAT WERE NOT FUNCTIONING,
CATHETER, ABLATION, ENDOMETRIAL GYNECARE WORLDWIDE A DIV OF ETHICON, INC.:SURGICAL TECH WAS GIVEN THE STERILE EQUIPMENT AND HANDED IT TO THE PHYSICIAN. WHEN HE WENT TO FILL
CATHETER, ABLATION, ENDOMETRIAL HOLOGIC, INC.:WHILE DOCTOR WAS USING THE NOVASURE ABLATION INSTRUMENT, THE DISPOSABLE HANDPIECE DID NOT HAVE A PRO
CATHETER, ABLATION, RF, CARDIAC BIOSENSE WEBSTER:ONCE THE CATHETER WAS INSERTED INTO THE PATIENT DURING THE PROCEDURE, IT WAS NOTED THERE WAS NOT A S
CATHETER, ABLATION, RF, CARDIAC BOSTON SCIENTIFIC:THE BLAZER II HTD ABLATION CATHETER WAS TESTED PRIOR TO INSERTION INTO THE BODY AND THE MECHANISM WA
CATHETER, ANAL RECTAL MANOMATORY CLINICAL INNOVATIONS, LLC:PROBE WAS CALIBRATED AND CHANNELS TESTED TO MAKE SURE THEY WORKED. WHEN PROBE WAS PLACED IN THE PATI
CATHETER, ANGIOPLASTY, PERIPHERAL ANGIOSCORE:PATIENT HAD IN-STENT RESTENOSIS OF A TORTUOUS, CALCIFIED, LEFT INTERNAL CAROTID ARTERY LESION; PLAN
CATHETER, ANGIOPLASTY, PERIPHERAL BARD PERIPHERAL VASCULAR INC.:A PATIENT WITH PREVIOUS MEDICAL HISTORY OF PERIPHERAL VASCULAR DISEASE (PVD) WAS ADMITTED WITH INCRE
CATHETER, ANGIOPLASTY, PERIPHERAL CORDIS:DURING ANGIOPLASTY, THE BALLOON CATHETER WAS PLACED INTO THE ILIAC ARTERY. THE DOCTOR INFLATED THE B
CATHETER, ANGIOPLASTY, PERIPHERAL EV3:DURING BALLOON VENOPLASTY OF A DIALYSIS FISTULA, 10MM X 40MM EVERCROSS BALLOON RUPTURED. PART OF THE
CATHETER, ANGIOPLASTY, PERIPHERAL EV3 INC.:EQUIPMENT MALFUNCTION WHICH CAUSED BLEEDING DURING INTERVENTIONAL RADIOLOGY PROCEDURE. PT UNDERWENT
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA BOSTON SCIENTIFIC - GALWAY:IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE,THE BALLOON WOULD NOT
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA BOSTON SCIENTIFIC - LETTERKENNY:IT WAS REPORTED THAT DURING AN ILIAC PROCEDURE A DISSECTION OCCURRED. THE 75% STENOSED LESION WAS LO
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA BOSTON SCIENTIFIC CORPORATION-LETTERKENNY:(B) (4) PERIPHERAL CUTTING BALLOON REGISTRY.IT WAS REPORTED THAT IN (B) (6) 2006 THE PATIENT UNDERWE
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL BOSTON SCIENTIFIC - GALWAY:(B) (4).
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL BOSTON SCIENTIFIC CORPORATION-LETTERKENNY:DATE OF EVENT - (B) (6) 2005. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE AN
CATHETER, ARTERIAL, RADIAL TELEFLEX MEDICAL:THE ANESTHETIST WAS ATTEMPTING TO PLACE A RADIAL ARTERY CATHETER IN A CHILD. THE ARTERY WAS NOT CANN
CATHETER, ARTHERECTOMY CARDIOVASCULAR SYSTEMS, INC:A DIAMONDBACK 2.00 ORBITAL ATHERECTOMY DEVICE WAS USED IN THE SUPERFICIAL FEMORAL ARTERY TO TREAT TW
CATHETER, ASPIRATION MEDRAD, INC:PHYSICIAN PERFORMING A SELECTIVE RIGHT CORONARY ARTERY ANGIOGRAPHY WITH PLACEMENT OF OVERLAPPING DRU
CATHETER, BALLOON TYPE BOSTON SCIENTIFIC - MAPLE GROVE:CONCLUSION: ANTICIPATED PROCEDURAL COMPLICATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR)WAS PERF
CATHETER, BALLOON TYPE NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.:THE OCCLUSION OF THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY (ICA) AND MIDDLE CEREBRAL ARTERY (MCA) W
CATHETER, BALLOON, TRANSCERVICAL ETHICON, INC.:CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMEN
CATHETER, BILIARY, DIAGNOSTIC BOSTON SCIENTIFIC:THE DEVICE (DELIVERY SYSTEM) HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE
CATHETER, BILIARY, DIAGNOSTIC BOSTON SCIENTIFIC - CORK:THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE THE LOT EXPIRATION AN
CATHETER, BILIARY, DIAGNOSTIC BOSTON SCIENTIFIC - GALWAY:IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF
CATHETER, BILIARY, DIAGNOSTIC BOSTON SCIENTIFIC - MAPLE GROVE:IT WAS REPORTED THAT DURING AN EXTERNAL ILIAC INTERVENTIONAL PROCEDURE, STENT DEPLOYMENT DIFFICULTIE
CATHETER, BILIARY, DIAGNOSTIC BOSTON SCIENTIFIC - MARLBOROUGH:IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS USED D
CATHETER, BILIARY, DIAGNOSTIC BOSTON SCIENTIFIC - SPENCER:THERAPY/NON-SURGICAL TREATMENT, ADDITIONAL.
CATHETER, BRACHYTHERAPY HOLOGIC, INC.:MAMMOSITE CATHETER HAD A HOLE IN THE BALLOON. DID NOT REACH THE PATIENT.
CATHETER, BRACHYTHERAPY, BREAST HOLOGIC, INC.:PATIENT WAS IN FOR SURGERY FOR RE-EXCISION RIGHT BREAST LUMPECTOMY, SENTINAL NODE MAPPING/BIOPSY, AN
CATHETER, CARDIOVASCULAR ARROW INTERNATIONAL INC:A TRIPLE-LUMEN CATHETER WAS PLACED IN THE RIGHT FEMORAL VEIN BY PHYSICIAN. PATIENT WAS ADMITTED TO
CATHETER, CARDIOVASCULAR ARROW INTERNATIONAL INC.:APPROXIMATELY FOUR (4) MM CATHETER TIP OF ARROW QUICK FLASH RADIAL ARTERY CATHETERIZATION SET BROKE
CATHETER, CARDIOVASCULAR ARROW/TELEFLEX MEDICAL:BURN PATIENT NEEDED A CENTRAL LINE PLACED FOR FLUID RESUSITATION. NURSE PRACTITIONER PLACED THE SUB
CATHETER, CARDIOVASCULAR BOSTON SCIENTIFIC:MONORAIL TIP OF .018 IVUS CATH BOUND ON WIRE, AND COULD NOT BE REMOVED OUT OF VESSEL. THE USER HAD T
CATHETER, CARDIOVASCULAR HOSPIRA GLOBAL MEDICAL AFFAIRS.:REGISTERED NURSE CONNECTED CONTRAST INJECTOR TO CENTRAL LINE. AT SOME POINT, EITHER DURING INJECTIO
CATHETER, CARDIOVASCULAR TELEFLEX MEDICAL:A FEMORAL CATHETER WAS PLACED IN A CHILD'S FEMORAL ARTERY. AFTER A DAY IT CRACKED AND STARTED TO LEA
CATHETER, CARDIOVASCULAR, BALLOON TYPE HOSPIRA:THE BRIDGE ATTACHED TO THE PULMONARY ARTERY (PA) CATHETER BROKE. THIS CAUSED THE END OF THE YELLOW
CATHETER, CENTRAL VENOUS MEDCOMP:DURING A PROCEDURE, THE ATTACHING END OF THE TUNNELER BROKE OFF MAKING THE PROLINE CATHETER ALMOST U
CATHETER, CENTRAL VENOUS TELEFLEX MEDICAL:THE PATIENT ARRESTED IN THE AMBULANCE EN ROUTE TO THE ED. A FEMORAL TLC (TRIPLE LUMEN CATHETER) WAS
CATHETER, CONTINUOUS FLOW COVIDIEN:AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
CATHETER, CORONARY, ATHERECTOMY BOSTON SCIENTIFIC:ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOLLOWING A FAL
CATHETER, CORONARY, ATHERECTOMY BOSTON SCIENTIFIC - CORK:IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY AND ROTATIONAL ATHERECT
CATHETER, CORONARY, ATHERECTOMY BOSTON SCIENTIFIC - FREMONT:THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS O
CATHETER, CORONARY, ATHERECTOMY BOSTON SCIENTIFIC - MIAMI:(B) (4)
CATHETER, CORONARY, SINUS EDWARDS LIFESCIENCES:RUPTURED BALLOON ON CORONARY SINUS CATHETER. THE LINE WAS PLACED, BALLOON WORKED INITIALLY THEN RUP
CATHETER, DIALYSIS COVIDIEN:THE RED AND BLUE PORTS WERE SWITCHED AND DID NOT PROPERLY REFLECT THE ARTERIAL/VENOUS PORTS. THIS CA
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE BOSTON SCIENTIFIC - SAN JOSE:IMPLANTED AN LD LEAD AND DURING THE PROCEDURE, THEY USED A 6 FRENCH BSC POLARIS EP AND DISSECTED THE
CATHETER, FOLEY BARD:PATIENT HAD FOLEY CATHETER IN PLACE. WHEN THE RN ATTEMPTED TO REMOVE THE CATHETER SHE WAS UNABLE TO
CATHETER, FOLEY BARD UROLOGICAL:WHILE REMOVING PATIENT'S FOLEY CATHETER, THE TIP BECAME STUCK AT THE TIP OF THE PATIENT'S PENIS (THE
CATHETER, FOLEY BARD UROLOGICAL DIVISION:URINARY CATHETER BALLOON DEFLATED SPONTANEOUSLY AND CATHETER FELL OUT OF PATIENT. CRACK NOTICED IN C
CATHETER, FOLEY, TEMPERATURE SENSING C.R. BARD, INC.:THESE TEMPERATURE SENSING FOLEYS ARE A NEW PRODUCT FOR OUR HOSPITAL. THIS VERSION IS SILICONE WITH A
CATHETER, IMPLANTED, FECAL HOLLISTER INCORPORATED:ACTIFLO RECTAL TUBE WAS PLACED TO DECOMPRESS GUT. PATIENT EXPERIENCED A RECTAL PERFORATION LIKELY CA
CATHETER, IMPLANTED, PORT BARD:ON ROUNDS THE NURSE FOUND THE MEDIPORT DRESSING SATURATED WITH ORANGE COLORED FLUID. ADRIAMYCIN WAS
CATHETER, IMPLANTED, PORT BARD ACCESS SYSTEMS:PATIENT HAD BEEN RECEIVING CHEMOTHERAPY AS AN OUTPATIENT THROUGH A RIGHT SUBCLAVIAN MEDIPORT. THE PA
CATHETER, INTRA-AORTIC BALLOON DATASCOPE CORPORATION, CARDIAC ASSIST DIVISION:THE INTRA-AORTIC BALLON PRESSURE LINE FAILED TO BACK BLEED. SEEMED TO BE AN OBSTRUCTION AT THE PRESS
CATHETER, INTRAVASCULAR NAVILYST MEDICAL:NOTIFICATION WAS MADE TO NAVILYST BY THE DAUGHTER OF THE PATIENT. THE PATIENT HAD BEEN IN THE HOSPIT
CATHETER, INTRAVASCULAR UNK:ANGIO REMOVED TIP OF CATHETER FROM PATIENT.
CATHETER, INTRAVASCULAR, DIAGNOSTIC ABIOMED, INC.:AN IMPELLA 2.5 LEFT VENTRICULAR DEVICE CATHETER PUMP WAS INSERTED THROUGH A HEMASHIELD GRAFT, SEWED
CATHETER, INTRAVASCULAR, DIAGNOSTIC BOSTON SCIENTIFIC - CORK:ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE DISTAL TIP SECTION OF THE CATHETER WAS MISSING. THIS
CATHETER, INTRAVASCULAR, DIAGNOSTIC BOSTON SCIENTIFIC - FREMONT:THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS USED IN A MID LEFT ANTERIOR DESCENDING (LAD) POST A
CATHETER, INTRAVASCULAR, DIAGNOSTIC BOSTON SCIENTIFIC - MAPLE GROVE:THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS USED IN A MID LEFT ANTERIOR DESCENDING (LAD) POST A
CATHETER, INTRAVASCULAR, DIAGNOSTIC BOSTON SCIENTIFIC CORPORATION:NEW CODE REQUEST HAS BEEN SUBMITTED FOR STUCK IN STENT.
CATHETER, INTRAVASCULAR, DIAGNOSTIC HOSPIRA GLOBAL MEDICAL AFFAIRS:SWAN-GANZ CATHETER BALLOON AVULSED OFF OF CATHETER IN REMOVING CATHETER FROM THE PATIENT. PATIENT MO
CATHETER, INTRAVASCULAR, DIAGNOSTIC MERIT MEDICAL SYSTEMS, INC:DEVICE EVALUATION: ACTUAL SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HIS
CATHETER, INTRAVASCULAR, DIAGNOSTIC MERIT MEDICAL SYSTEMS, INC.:THE COMPLAINANT REPORTED THAT AIR ENTERED THE SYSTEM AND WAS INJECTED INTO THE PT DURING A LEFT CORO
CATHETER, INTRAVASCULAR, IMAGING BOSTON SCIENTIFIC:AN IVUS CATHETER WAS ADVANCED OVER AN INTERVENTIONAL GUIDEWIRE INTO THE PATIENT'S LEFT ANTERIOR DESC
CATHETER, INTRAVASCULAR, PICC,5 FRENCH DUAL LUMEN BARD ACCESS SYSTEMS:A PICC LINE WAS PLACED WITHOUT INCIDENT. A LINEAR HYPERDENSITY OF AN UNKNOWN ETIOLOGY WAS OBSERVED O
CATHETER, INTRODUCER TERUMO:A PATIENT WITH PREVIOUS MEDICAL HISTORY OF PERIPHERAL VASCULAR DISEASE (PVD) WAS ADMITTED WITH INCRE
CATHETER, IRRIGATION MERIT MEDICAL SYSTEMS, INC.:DEVICE EVAL: THE SUSPECT DEVICE WAS NOT RETURNED FOR EVAL. COMPLAINT COULD NOT BE CONFIRMED. THE PHY
CATHETER, IV BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.:WHEN THE NURSE TRIED TO INSERT THE NEEDLE, SHE MET SOME RESISTANCE. SHE PULLED THE NEEDLE OUT AND F
CATHETER, PERCUTANEOUS BOSTON SCIENTIFIC - GALWAY:IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE A BALLOON RUPTUR
CATHETER, PERCUTANEOUS BOSTON SCIENTIFIC - MAPLE GROVE:SAME CASE AS: 2134265-2010-00915, 2134265-2010-00916, 2134265-2010-00917, 2132134265-2010-00919, 213
CATHETER, PERCUTANEOUS CONCENTRIC MEDICAL, INC.:PATIENT WAS A MALE WHO PRESENTED WITH STROKE SYMPTOMS. MECHANICAL THROMBECTOMY WAS FIRST ATTEMPTED W
CATHETER, PERCUTANEOUS EV3 INC.:WHILE IN USE, THE BALLOON WOULD NOT STAY INFLATED; IT KEPT DEFLATING. IT WAS FELT THAT THE BALLOON H
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREA BOSTON SCIENTIFIC - SAN JOSE:THE PHYSICIAN WAS PROLAPSING THE DEVICE OVER THE AORTA INTO THE LEFT VENTRICLE AND THE CATHETER WOUL
CATHETER, PERIPHERAL, ATHERECTOMY PATHWAY MEDICAL TECHNOLOGIES, INC.:WHILE PERFORMING A ATHRECTOMY/THROMBECTOMY WITH THE PATHWAY JETSTREAM DEVICE, THE GRAND SLAM GUIDEWI
CATHETER, PICC BARD ACCESS SYSTEMS:RN WAS INSERTING A PICC IN PATIENT'S RIGHT ARM. THE GUIDE WIRE FRAYED AND WAS LODGED IN THE PATIENT
CATHETER, PICC BD MEDICAL SYSTEMS:NIGHT NURSE COMPLETED A HEEL STICK ON THE INFANT AND NOTED EDEMA ON THE INFANT'S CHEST AREA. UPON FU
CATHETER, PICC TELEFLEX MEDICAL:THE PRACTITIONER WAS CALLED IN THE MORNING REGARDING A "DEFECTIVE PICC" BY A NURSE IN THE ICU. THE
CATHETER, TRANSLUMINAL CORONARY ANGIOPLASTY ABBOTT:DURING THE PROCEDURE, THE DILATATION BALLOON WAS ADVANCED OVER THE BALANCE MIDDLEWEIGHT (BMW) UNIVER
CATHETER, ULTRASOUND, INTRAVASCULAR ASCENT HEALTHCARE SOLUTIONS:THE REPROCESSED CATHETER HAS UNSATISFACTORY ULTRASOUND IMAGING. NO HARM CAME TO THE PT.
CATHETER, UMBILICAL TYCO HEALTHCARE/KENDALL:A FULL TERM INFANT WAS DELIVERED VIA C-SECTION. THE INFANT WAS ADMITTED TO THE NURSERY AND REPORTED
CATHETER, UMBILICAL UTAH MEDICAL:THE UVC WAS AT THE 8.5CM MARK AND IT WAS BEING PULLED BACK TO THE 7.5CM MARK AS PER THE MD ORDER. TH
CATHETER, VASCULAR COOK MEDICAL:PATIENT WITH A CENTRAL LINE IN PLACE TO THE RIGHT SUBCLAVIAN. THE DOCTOR PREPARED TO CHANGE THE LINE
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERC BOSTON SCIENTIFIC:IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE A FAILURE ANALYSIS OF THE C
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERC BOSTON SCIENTIFIC - GALWAY:(B) (6).(B) (4).
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERC BOSTON SCIENTIFIC - LETTERKENNY:SAME CASE AS 2134265-2010-01489. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERC BOSTON SCIENTIFIC - MAPLE GROVE:DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FO
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERC BOSTON SCIENTIFIC CORPORATION:SAME CASE AS MFR#: 2134265-2010-00412, 2134265-2010-00430, 2134265-2010-00429. IT WAS REPORTED THAT
CAUTERY BOVIE MEDICAL:BOVIE MEDICAL PROVIDES WARNINGS THAT CONTRAINDICATE THE USE OF THE DEVICE WHILE USING FLAMMABLE MATE
CAUTERY DEVICE MEDTRONIC:DURING CASE (BILATERAL INFERIOR OBLIQUE MYECTOMY AND BILATERAL MEDIAL RECTUS RECESSION), THE MEDTRON
CAUTERY PENCIL CON-MED:THERE WAS A MALFUNCTION OF THE OPERATION SWITCH ON A CON-MED, CAUTERY PENCIL. DURING THE INITIAL INC
CAZ - ANESTHESIA CONDUCTION KIT SMITHS MEDICAL ASD, INC.:MANUFACTURE COMPLETED THE ENTIRE FORM. CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER
CBK VENTILATOR, CONTINOUS, FACILITY USE CARFUSION:THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RES
CEILING STRAP BARTON MEDICAL:THE CEILING STRAP FELL ON AN EMPLOYEE'S HEAD. PER BIOMED, THE BENDING OF THE STITCHED END OF THE STR
CELLEX THERAKOS:THE THERAKOS FIELD ENGINEER ARRIVED AT THE SITE IN 2009 TO EVALUATE THE DEVICE. THE DEVICE WAS FOUND
CELLEX PROCEDURE KIT THERAKOS:A CELLEX INSTRUMENT COLLECTION PUMP TUBING LEAKAGE WAS DISCOVERED DURING THE ECP TREATMENT. THERE WA
CEMENT, DENTAL KERR CORPORATION:IN 2009, A DOCTOR ALLEGED THAT TEMPBOND CLEAR TEMPORARY CEMENT CAUSED INCREASED SENSITIVITY IN PATIE
CEMENT, DENTAL PENTRON CLINICAL TECHNOLOGIES:IT WAS REPORTED THAT A CROWN THAT HAD BEEN CEMENTED WITH NATURAL ELEGANCE RESIN CEMENT HAD DEBONDED
CENTER POINT LEAK WITH FLOATING FLANGE, SKIN BARRI HOLLISTER, INC. (HOLLISTER):POUCH POPS OFF FACEPLATE, WONT STAY ON. MANUFACTURER MUST HAVE REALIZED THIS PRODUCT WAS FAULTY WHEN
CENTESIS CATHETER PIG1260T CARDINAL HEALTH:CENTESIS CATHETER PLACED AND LEAKED.
CENTRAL MONITORING SYSTEM GE HEALTHCARE:A CUSTOMER REPORTED THAT A PT HAD A VENTRICULAR FIBRILLATION (VFIB) EPISODE, AND THE DEVICE DID NOT
CENTRAL NERVOUS SYSTEM & COMPS CODMAN & SHURTLEFF, INC:AFFILIATE REPORTED THAT THERE WAS LEAKAGE FROM THE SPLICE BETWEEN THE CONNECTOR AND THE CATHETER.
CENTRAL VENOUS ACCESS INTRODUCER EDWARDS LIFESCIENCES, PR:THE CUSTOMER IS HOLDING ON TO THE DEVICE AND IS NOT GOING TO RETURN IT AT THIS TIME.
CENTRAL VENOUS CATHETER EDWARDS LIFESCIENCES, PR:
CERAMIC BALL HEAD / JDH AARAU SWITZERLAND MANUFACTURING SITE:A REVISION WAS REPORTED DUE TO FRACTURE OF THE INSERT AND BALL HEAD.
CERAMIC-ON-CERAMIC HIP IMPLANT STRYKER:STRYKER OSTEONICS TRIDENT CERAMIC-ON-CERAMIC HIP REPLACEMENT IS SQUEAKING AND CRUNCHING. THIS MODEL
CERVICAL CUP COOPER SURGICAL, INC.:DURING THE LAPAROSCOPIC SUPRA-CERVICAL HYSTERECTOMY PROCEDURE, THE KOH UTERINE MANIPULATOR WAS INSER
CERVICAL DISC REPLACEMENT SPINAL MOTION, INC - INELFEX:IN (B) (6) 2006, THE DISC BETWEEN C6 & C7 HERNIATED. IN (B) (6) 2006, I HAD A CERVICAL DISC REPLACEM
CERVICAL FIXATION DEVICE DEPUY SPINE, INC.:SURGEON REMOVED A 2-LEVEL UNIPLATE DUE TO ONE SCREW HAVING BACKED OUT APPROX. 3MM. REPORTS THAT CAM
CERVICAL PLATE CORIN USA:I AM HAVING NECK, SHOULDER AND LEFT ARM PAIN. I ALSO HAVE MIGRAINE AND SINUS HEADACHES, SWELLING OF
CERVICAL PLATE WARSAW ORTHOPEDIC INC.:IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL SURGERY WITH INSTRUMENTATION FROM C5 TO C7. THE PA
CERVICAL PLATE SPINAL SYSTEM X-SPINE SYSTEMS, INC.:PROCEDURE TYPE: SPINAL SURGERY - THREE LEVEL C3-C7 FUSION. ACCORDING TO THE REPORTER: 6 MONTHS AFTER
CES MICROCATHETERS (KRA) CORDIS NEUROVASCULAR, INC.:
CHEMISTRY ANALYZER SIEMENS HEALTHCARE DIAGNOSTICS INC.:THE CUSTOMER HAD MANUALLY REPORTED THE PHENYTOIN RESULTS OUT AS < 0.8 WHEN THE ADVIA 1800 REPORTED R
CHEMOTHERAPY CLOSED SYSTEM TRANSFER DEVICE-CLOSED ICU MEDICAL:MANUFACTURED PATIENT'S CHEMOTHERAPY DOXORUBICIN. ATTACHED ICU MEDICAL SPIROS CLOSED MALE CONNECTOR W
CHEMOTHERAPY CLOSED SYSTEM TRANSFER DEVICE-CLOSED ICU MEDICAL, INC.:IN THE PROCESS OF COMPOUNDING AN IV CHEMOTHERAPY WITH CYTOXAN, THE SPIROS SYRINGE ADAPTER -MFG BY IC
CHG IV SECUREMENT DRESSING 3M HEALTH CARE:THE FACILITY REPORTED THAT THEY OBSERVED SOMETHING THAT LOOKED LIKE A SKIN TEAR UNDER THE GEL PAD, A
CHG IV SECUREMENT DRESSING 3M HEALTHCARE:HEALTHCARE FACILITY REPORTED THAT THE TEGADERM CHG DRESSING WAS USED ON A PICC LINE OF AN IN-PATIENT
CHRONIC HEMODIALYSIS CATHETER PRODUCTS ARROW INTL., INC.:SAMPLE WILL NOT NOT BE RETURNED FOR EVALUATION.
CHRONOS GRANULES SYNTHES (USA):ADD'L INFO HAS BEEN REQUESTED. SYNTHES IS UNABLE TO PROVIDE THE MFR, PMA/510K AND/OR DATE OF MANUFAC
CHRONOS STRIP SYNTHES (USA):PT STATUS POST POSTERIOR LUMBAR FUSION L3 TO S1 WITH CHRONOS GRANULES AND CHRONOS STRIP RETURNED TO
CI COCHLEAR AMERICAS:FIRST, THEY DIDN'T TELL US, WHILE DESCRIBING THE IMPLANT DEVICE INTERNALLY THAT MY CHILDREN WOULD NO
CIRCULAR STAPLERS ETHICON ENDO-SURGERY, LLC.:INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFI
CIRCUMCISION CLAMP ALLIED HEALTHCARE PRODUCTS INC:CIRCUMCISION CLAMP WAS USED DURING CIRCUMCISION PROCEDURE. THE CLAMP FAILED TO UNSCREW WHILE ON THE
CIRCUMCISION RING ALLIED HEALTHCARE PRODUCTS, INC.:INFANT WAS BEING CIRCUMCISED BY DR (B) (6). DURING THE PROCEDURE, THE METAL BASE BROKE. A NEW GOMCO
CLAMP CAREFUSION:NO INSTRUMENT WAS RECEIVED FOR EVALUATION. SINCE NO SAMPLE WAS RECEIVED, OUR TEAM COULD NOT VALIDATE
CLAMP, ABLATION, CARDIAC, SURGICAL ATRICURE:THE MALFUNCTIONING DEVICE WAS A DISPOSABLE PULMONARY ARTERY CLAMP KNOWN AS AN ATRICURE. IT WAS SUPP
CLAMP, CIRCUMCISION ALLIED HEALTHCARE PRODUCTS:DURING THE PROCEDURE, THE GOMCO APPEARED TO NOT HOLD TIGHTLY AND CAME UNDONE. THERE ARE TWO DIFFEREN
CLAMP, VASCULAR EDWARDS LIFESCIENCE:DURING ROBOTIC MITRAL VALVE REPAIR, THE CARDIOVATIONS ENDOCLAMP BALLOON RUPTURED, WHICH ENABLED THE
CLAMP, VASCULAR RADI -ST. JUDE MEDICAL:THE FEMOSTOP RED TAG WAS REMOVED AND THE BALLOON WAS CHECKED AND INFLATED. IT WAS ALRIGHT PRIOR TO T
CLAMP, VASCULAR RADI MEDICAL SYSTEMS AB:ACCORDING TO THE EVENT DESCRIPTION ((B) (6)), THERE WAS "NO DIGITAL DISPLAY" AND THAT THE FEMOSTOP W
CLASS IV DIODE LASER DIOMED, LTD. (C/O ANGIODYNAMICS):LASER HAS BEEN FULLY EVALUATED BY ANGIODYNAMICS SERVICE DEPARTMENT AND FOUND TO BE OPERATING FULLY W
CLAVICLE INTRAMEDULLARY BONE FIXATION SONOMA ORTHOPEDIC PRODUCTS INC.:RECEIVED A REPORT THAT PT DEVELOPED INFECTION AT SURGICAL SITE FROM CLAVICLE IMPLANT, IDENTIFIED AS
CLEANING AND DISINFECTING SOLUTION CIBA VISION CORP:I HAVE BEEN WEARING CONTACT LENSES FOR OVER 30 YEARS AND HAVE USED MANY DIFFERENT BRANDS OF PRODUCTS
CLEAR CARE CIBA VISION:MISTAKENLY USED CLEAR CARE BRAND ONE BOTTLE CONTACT SOLUTION BY CIBA IN MY EYE AS I THOUGHT IT WAS A
CLEARGLIDE SORIN GROUP:BIPOLAR ENDO DEVICE BROKE OFF WHILE USING.
CLINCAL CHEMISTRY ANALYZER ROCHE DIAGNOSTICS:.
CLINCIAL CHEMISTRY ANALYZER ROCHE DIAGNOSTICS:THE USER RECEIVED AN ERRONEOUS CALCIUM RESULT FOR ONE PATIENT SAMPLE. THE ORIGINAL RESULT WAS 2.7 MG
CLINICAL CHEMISTRY ANALYZER ROCHE DIAGNOSTICS:THE USER STATED THEIR RESULTS DID NOT COMPARE WELL WITH THE PEER GROUP RESULTS FOR A THERAPEUTIC DRU
CLINICAL CHEMISTRY ANALYZER - JJE ROCHE DIAGNOSTICS:CUSTOMER RECEIVED FALSE LOW DIGOXIN RESULTS FOR ONE PT. THE DIGOXIN RESULT WAS LESS THAN 0.2 NG PER
CLINICAL CHEMISTRY ANALYZER-JJE ROCHE DIAGNOSTICS:THE USER EXPERIENCED ISSUES WITH THE ISE MODULE AND RECEIVED LOW SODIUM RESULTS FOR FOUR PT PLASMA S
CLIP APPLIER COVIDIEN UNITED STATES SURGICAL:ATTEMPTED TO USE AUTOSUTURE AND IT MISFIRED.
CLIP APPLIER COVIDIEN UNITED STATES SURGICAL CORPORATION:PHYSICIAN TRIED TO STAPLE A VESSEL AND THE STAPLER MISFIRED.
CLIP APPLIER COVIDIEN US SURGICAL:THE CLIPS WERE NOT CLOSING COMPLETELY.
CLIP APPLIER ETHICON ENDO SURGERY INC.:ETHICON PROXIMATE 35 CLIP APPLIER FAILED. NO INJURY TO PT. PACKAGING NOT PROVIDED, UNABLE TO OBTAIN
CLIP APPLIER ETHICON ENDO-SURGERY:PATIENT IN FOR A LAPAROSCOPIC CHOLECYSTECTOMY. THE SURGEON USED ETHICON LIGACLIP 10 M/L. THE FIRST
CLIP APPLIER ETHICON ENDO-SURGERY, INC.:THE 5MM STAPLER WAS USED ON THE CYSTIC ARTERY AND THE CLIP HAD FIRED A STAPLE THAT DID NOT FIRE EVEN
CLIP APPLIER ETHICON ENDO-SURGERY, LLC:CLIP APPLIER PLACED A CLIP ON THE ARTERY, BUT WOULD NOT RELEASE THE CLIP.
CLIP APPLIER ETHICON ENDOSURGERY:THE CLIP APPLIER WAS AT THE LAST CLIP. WHEN THE DOCTOR DISCHARGED IT, THE CLIP APPLIER STUCK AND WOU
CLIP APPLIER STERILMED, INC:CLIPS DID NOT FULLY CLOSE.
CLIP, IMPLANTABLE BOSTON SCIENTIFIC:ATTENDING PHYSICIAN NOTICED TWO SMALL SILVER FOREIGN BODIES IN THE DUODENAL AREA AFTER THREE (3) RES
CLIP, IMPLANTABLE ETHICON ENDO-SURGERY, LLC.:(B) (4). STICKING JAW/CAM,JAWS UNABLE TO OPEN_OPEN AFTER ASSISTED,MALFORMED CLIP THE ANALYSIS RESULT
CLOSED MALE CONNECTOR ICU MEDICAL, INC:CHEMO PHARMACIST AND TECHNICIAN WENT TO PREPARE CHEMOTHERAPY IN BIOLOGICAL SAFETY CABINET. TECHNICIA
CLOSED SUCTION SYSTEM T-PIECE KIMBERLY-CLARK:THIS PT CAME TO OUR EMERGENCY DEPARTMENT AFTER A SERIOUS ALLERGIC REACTION TO MEDICATION AT HOME. SH
CLOSED SYSTEM DRUG TRANSFER DEVICE/ BAG IV KT W/ C ICU MEDICAL:PHARMACY SENT DOSE OF BUSULFAN TO FLOOR FOR 1400 DOSE. FOLLOWING INSPECTION OF THE DOSE, NURSING REP
CLOSED WOUND SUCTION SYSTEM (JP DRAIN) C.R. BARD, INC.:AS OF TODAY'S DATE, THE SAMPLE HAS NOT YET BEEN RECEIVED FROM THE USER FACILITY. A DHR REVIEW COULD
CLOSED WOUND SUCTION SYSTEM -JP DRAIN- CARDINAL HEALTH:A -CARDINAL HEALTH JACKSON-PRATT CHANNEL DRAIN-CLOSED WOUND SUCTION SYSTEM WAS PLACED IN THIS PATIEN
CLS ACETABULAR COMPONENT ZIMMER GMBH:IT IS REPORTED THAT THE CLS CUP BROKE.
CLS ACETABULAR COMPONENT (MODIFICATION) ZIMMER GMBH:(B) (4). (B) (4). CONCLUSION: THE INVESTIGATION SHOWS THAT THE CAUSE OF THE BREAKAGE WAS FATIGUE DUE
CLS ACETABULAR COMPONENT (MODIFICTION) ZIMMER GMBH:IT WAS REPORTED THAT THE ACETABULAR COMPONENT WAS LOOSENING.
CLS SPOTORNO STEM ZIMMER GMBH:IT IS REPORTED THAT PT WAS REVISED DUE TO DISTINCTIVE METALLOSIS AND OSTEOLYSIS IN THE FEMUR AREA. P
CNS EXTERNAL DRAINAGE SYSTEM CODMAN & SHURTLEFF, INC.:UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.
CNS SHUNT CODMAN & SHURTLEFF, INC. MEDOS S.A.:AFTER THE INITIAL SURGERY, FLUID DID NOT FLOW THROUGH THE DEVICE. AS A RESULT, THE DEVICE WAS REPLAC
CNS SHUNT CODMAN & SHURTLEFF, INC., MEDOS S.A.:UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.
CNV DCS ORBIT (HCG) CORDIS NEUROVASCULAR, INC.:THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WI
CNV ENTERPRISE SES (NJE) CORDIS NEUROVASCULAR, INC.:THE REPORT RECEIVED FROM THE FIELD INDICATED THAT APPROX TWO MONTHS AFTER THE INTERVENTIONAL NEUROVA
CO2 DETECTOR COVIDIEN NELLCOR:BURN PATIENT REQUIRED INTUBATION. BURN MD INTUBATED PATIENT AND USED A NELLCOR EASY CAP II CO2 DETE
COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESS KARL STORZ ENDOSCOPY-AMERICA, INC.:FROM SURGEON'S DICTATION, "DURING A LAPAROSCPOIC TUBAL LIGATION; THE RIGHT FALLOPIAN TUBE WAS IDENT
COCHEAR IMPLANT MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH:THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILA
COCHLEAR IMPLANT ADVANCED BIONICS CORP:ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE PT'S DEVICE R
COCHLEAR IMPLANT ADVANCED BIONICS LLC:THE PATIENT'S ELECTRODE ARRAY REPORTEDLY MIGRATED FROM THE COCHLEA. REVISION SURGERY TO REPOSITION T
COCHLEAR IMPLANT COCHLEAR AMERICAS:PATIENT LOST HEARING IN 2003 FOLLOWING PNEUMOCOCCAL MENINGITIS. SHE UNDERWENT IMPLANTATION ON THE RI
COCHLEAR IMPLANT MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH:THE DEVICE HAS NOT YET BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MANUFA
COCHLEAR IMPLANT MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH:IT WAS REPORTED THAT THE PT WAS EXPLANTED, HOWEVER, NO FURTHER INFO IS AVAILABLE AT THE MOMENT.
COCR SPINAL ROD, 600MM PIONEER SURGICAL:THE OPERATING SURGEON STATED THAT THE SPINAL ROD BROKE DUE TO THE HIGH LOAD AT THE END OF THE CONSTR
CODMAN DISPOSABLE PERFORATOR CODMAN & SHURTLEFF, INC.:AFFILIATE REPORTED THAT THE DEVICE FAILED TO DISENGAGEMENT. DURING THE SURGERY, PERFORATOR COULD NOT
COHCLEAR IMPLANT ADVANCED BIONICS LLC:THE COMPANY WAS INFORMED THAT THE PT DEVELOPED A SKIN FLAP INFECTION AND SKIN NECROSIS AT THE IMPLAN
COLD THERAPY SYSTEM EBI, LLC:IT HAS BEEN REPORTED THAT THE MOBILITY OF THE PLAINTIFF'S RIGHT FOOT AND ANKLE HAS WORSENED AFTER US
COLD THERAPY UNIT DJ ORTHOPEDICS DE MEXICO,:SERVICE OF SUMMONS AND COMPLAINT WAS MANUFACTURER'S FIRST NOTICE OF THIS EVENT. PLAINTIFF'S COUNSEL
COLOGAN FIDIA FARMACEUTICI S.P.A.:HYALGAN - SECOND INJECTION IN 2009, MIGRATED FROM KNEE JOINT TO WITHIN TISSUE OF LOWER LEG - CREATIN
COLONOSCOPE FUJINON CORP.:THE SUBJECT COLONOSCOPE HAS NOT BEEN RETURNED BY THE CUSTOMER FOR EVAL. THIS SN SCOPE HAS NOT BEEN I
COLONOSCOPE FUJINON CORPORATION:THE GI COORDINATOR REPORTED, A PT PERFORATION ON A SERVICE/RETURN NOTIFICATION FORM WHEN THE SUBJECT
COLONOSCOPE OLYMPUS MEDICAL SYSTEMS CORPORATION:OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA PHONE AND IN WRITING TO OBTAIN ADDITIONAL DETAILED IN
COLPOTOMIZER SYSTEM COOPERSURGICAL, INC.:DURING A ROBOTIC LAPAROSCOPIC HYSTERECTOMY, SOME VAGINAL MUCOSA WAS LODGED/STUCK BETWEEN THE RUMI HA
COMMODE DHARMA POLIMETAL, PT:THE ALLEGED PRODUCT WAS RETURNED TO OUR CUSTOMER FOR EVALUATION. THE ALLEGED COMMODE WAS HEAVILY USE
COMPACT DIAGNOSTICA STAGO:THIS PT PRESENTED IN OUR ANTICOAGULATION CLINIC AND HAD AN INR RUN ON THE (B) (4) ISTAT. THE RESULT
COMPAIR NE C 25 ONRON:OMRON MAKES NEBULIZING EQUIPMENT. THEIR PRODUCT MODEL NE-C25 COMPAIR COMPRESSOR NEBULIZING SYSTEM HA
COMPRESSIBLE LIMB SLEEVE ARJOHUNTLEIGH:THE FACILITY REPORTS A CUSTOMER CALLED, STATING THAT AFTER ONE HOUR OF USE, HE IS DEVELOPING A PRESS
COMPRESSOR MEDTRONIC SOFAMOR DANEK:IT WAS REPORTED THAT THE SURGICAL SET PROVIDED DID NOT HAVE THE CORRECT SETSCREW COMPRESSION DRIVING
COMPUTED TOMOGRAPHY X-RAY SYSTEM SUPERDIMENSION INC.:PNEUMOTHORAX IS A KNOWN COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BI
COMPUTED TOMOGRAPHY X-RAY SYSTEM SUPERDIMENSION, LTD.:PNEUMOTHORAX IS A KNOWN COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BI
CONCEALABLE PENILE PROSTHESIS AMERICAN MEDICAL SYSTEMS, INC.:A (B) (6) MALE WITH DIABETES MELLITUS WAS IMPLANTED WITH A SPECTRA DEVICE ON (B) (6) 2009. INFORMATI
CONDOM SSL INTERNATIONAL, UK:SEVERAL CONDOMS IN THREE SEPARATE CASES OF 1000 DUREX ENHANCED PLEASURE CONDOMS WERE INSUFFICIENTLY
CONNECTOR WARSAW ORTHOPEDIC INC.:(B) (4): NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR
CONNECTOR, TUBING SET ICU MEDICAL, INC.:CHEMOTHERAPY GIVEN THROUGH PATIENT'S PORT. ALL CONNECTIONS INSPECTED AND TIGHTENED. CHEMOTHERAPY LEA
CONQUEST 10MMX4CM PRA BALLOON DILATION CATHETER BARD PERIPHERAL VASCULAR:ANGIOPLASTY BALLOON CATHETER RUPTURED DURING ROUTINE DILATATION OF PT'S LEFT ARM DIALYSIS GRAFT, RES
CONSTAVAC DRAIN STRYKER:CONSTAVAC DRAIN WOULD NOT TURN ON IN PACU. ANOTHER UNIT REQUESTED - OLD UNIT REMOVED AND PLACED IN B
CONTACT LENSES JOHNSON AND JOHNSON VISION CARE:I PLACED A NEW PAIR OF ACUVUE OASYS CONTACT LENSES ON AND NOTICED THAT MY VISION HAD NOT CHANGED AS
CONTINOUS AND PULSATILE IRRIGATION BULB UTAH MEDICAL PRODUCTS:NO PT INJURY OR INVOLVEMENT. THE PATHFINDER PLUS WAS VERY SLOW TO FILL, MEANING IT CANNOT BE USED FO
CONTINUOUS CARDIAC OUTPUT EDWARDS LIFESCIENCES, PR:CUSTOMER REPORT WAS NOT CONFIRMED. BALLOON INFLATED CLEARLY AND, CONCENTRICALLY, AND REMAINED INFLAT
CONTINUOUS CARDIAC OUTPUT CATHETER EDWARDS LIFESCIENCES, PR:
CONTINUOUS VENTILATOR DRAEGER MEDICAL AG & CO. KG:FURTHER INFORMATION ABOUT THE SET UP AND USE OF THE DEVICE DURING THE EVENT, RESULTS OF FURTHER TEST
CONTOUR ASCENCIA BAYER HEALTH CARE LLC:THERE ARE TWO PROBLEMS. FIRST, THE GLUCOSE VALUES REPORTED BY THE BAYER CONTOUR ASCENCIA METER, LIKE
CONTOUR ASCENICA BAYER HEALTH CARE LLC:THERE ARE TWO PROBLEMS. FIRST, THE GLUCOSE VALUES REPORTED BY THE BAYER CONTOUR ASCENCIA METER, LIKE
CONTROL PUMP WITH IZ AMERICAN MEDICAL SYSTEMS:THE PT UNDERWENT AN ARTIFICIAL URINARY SPHINCTER PLACEMENT. POSTOPERATIVELY, THE PT DEVELOPED URINA
CONTROLLER II ETHICON, INC.:NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FO
CONVENIENCE KIT ALCON - BELGIUM/S.A.ALCON-COUVREUR N.V.:INVESTIGATION INCLUDING ROOT CAUSE IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN
CONVENIENCE KIT ALCON - HOUSTON:THE SURGEON REPORTED THAT A PATIENT PRESENTED WITH A FIBER IN THE OD AT THE 1 DAY POST-OP EXAM. THE
CONVENIENCE TUBING PACK TERUMO CARDIOVASCULAR SYSTEMS CORPORATION:TERUMO DID NOT RECEIVE THE SUSPECT DEVICE FROM THE CUSTOMER, SO THE EVALUATION WAS LIMITED TO A REVI
CORD LUMITEX:PATIENT UNDERWENT CYSTOCELE REPAIR WITH MESH. WHEN DRAPES WERE TAKEN OFF OF THE PATIENT, A QUARTER S
CORD, ESU, RESECTOSCOPE OLYMPUS AMERICA, INC.:PATIENT HAVING A TURBT (TRANSURETHRAL RESECTION OF A BLADDER TUMOR), UTILIZING AN OLYMPUS RESECTOSCO
CORMET ACETABULAR CUP COMPONENT CORIN LTD.:PATIENT WAS REVISED ABOUT 8 YEARS AFTER IMPLANTATION.
CORMET ACETABULAR CUP COMPONENT CORIN, LTD.:PATIENT WAS REVISED ABOUT 8 YEARS AFTER IMPLANTATION AS THE ACETABULAR CUP WAS LOOSE.
CORMET FEMORAL HEAD COMPONENT CORIN LTD:ADDITIONAL INFO HAS BEEN REQUESTED FROM THE REPORTING SITE. (B) (64).
CORMET FEMORAL HEAD COMPONENT CORIN LTD, THE CORINIUM CENTRE,:PATIENT SUFFERS FROM PERTHES DISEASE WHICH IS A TYPE OF CONDITION CONTRA-INDICATED FOR THIS DEVICE.
CORONARY DRUG-ELUTING STENT BOSTON SCIENTIFIC:DEVICE EVALUATED BY MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE STENT WAS RET
CORONARY DRUG-ELUTING STENT BOSTON SCIENTIFIC - GALWAY:(B) (6).IT WAS REPORTED THAT POST A CORONARY ARTERY DRUG-ELUTING STENTING TREATMENT PROCEDURE, THE P
CORONARY DRUG-ELUTING STENT BOSTON SCIENTIFIC - MAPLE GROVE:IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A DRUG ELUTING STENT WAS IMPLAN
CORONARY DRUG-ELUTING STENT BOSTON SCIENTIFIC CORPORATION:IT WAS REPORTED THAT FOLLOWING A CORONARY STENTING TREATMENT PROCEDURE, A STENT FRACTURE OCCURRED. T
CORONARY SDS/STENTS (MAF) CORDIS CORPORATION:APPROXIMATELY SEVEN YEARS AFTER IMPLANTATION OF A CORDIS CROWN STENT AND AN AVE STENT, THE PT EXPERI
CORONARY SINUS CATHETER EDWARDS LIFESCIENCES:CUSTOMER REPORT WAS CONFIRMED. BALLOON WAS PARTIALLY INFLATED AND FILLED WITH BLOOD. BLOOD WAS ALSO
CORTEX SCREW SYNTHES MONUMENT:ADDITIONAL INFO HAS BEEN REQUESTED. MANUFACTURE DATE CANNOT BE DETERMINED WITHOUT A LOT NUMBER. INVE
CORTEX SCREWS, SELF-TAPPING SYNTHES (USA):ADD'L INFO HAS BEEN REQUESTED. INITIAL REPORT SOURCE WAS ANOTHER MEDICAL DEVICE COMPANY. DEVICE HIST
CORTEX SCREWS, SELF-TAPPING SYNTHES MONUMENT:ADDITIONAL INFO HAS BEEN REQUESTED. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DE
COT, AMBULANCE STRYKER:EMERGENCY MEDICAL TECHNICIANS (EMTS) WERE TRANSPORTING A PATIENT ON A STRETCHER FROM A BUILDING TO T
COTTON TEE WORN UNDER CHEST BRACE COMFORT PRODUCTS, INC..:(B) (6) WITH HX OF SCOLIOSIS HAD MRI OF SPINE AND BRAIN. SHE WAS ALLOWED TO WEAR A WHITE TEE SHIRT
CPACS MCKESSON CORP:A 100% OF ACQUIRED MEASUREMENTS/CALCULATIONS DID NO TRANSFER OVER TO THE STRUCTURED REPORT OF MCKESS
CPAP AIR SUPPLY HOSE AG INDUSTRIES:I USE A CPAP BREATHING MACHINE WHEN I SLEEP DUE TO SLEEP APNEA. I ROUTINELY OBTAINED A REPLACEMENT C
CPAP BREATHING MASK CIRCADIANCE LLC:CPAP MASK DID NOT FUNCTION AS INTENDED. PT FELT SHE WAS SUFFOCATING WHILE USING PRODUCT AS INTENDED.
CPOE CERNER:THERE IS A DROP DOWN MENU FOR MEDICATION DOSING FREQUENCY WITH MORE THAN 225 OPTIONS THAT HAS AN INA
CPOE ECLIPSYS:EVAL AND MANAGEMENT OF A NEUROLOGICAL INFECTION WAS DELAYED AND DIRECTLY ATTRIBUTED TO THE CPOE CONT
CPOE AND POWERCHART ELECTRONIC CARE RECORD DEVICES CERNER:THE EVENTS INVOLVED MISIDENTIFICATION OF PTS IN CONJUNCTION WITH TESTS INTENDED FOR ANOTHER PT BEING
CPOE, POWER CHART CERNER:HOSPITAL WIDE BREAKDOWN OF SYSTEM OF ELECTRIC CHARTS AND ELECTRIC ORDER GADGETS RESULTED IN CONFUSIO
CPOE, POWERCHART CERNER:VITAL DATA ON CRITICALLY ILL PT WAS MISSING FROM THE POWERCHART RECORD OVER A DURATION OF SEVERAL DA
CR READER FUJIFILM MEDICAL SYSTEM USA, INC.:AN X-RAY WAS TAKEN THAT WAS DOUBLE EXPOSED AND SHOULD HAVE BEEN REPEATED. THE AUTOCROPPING DID NOT D
CRANIOFACIAL DISTRACTOR SYNTHES MONUMENT:APPROXIMATE DATE OF EVENT REPORTED AS (B) (6) 2009. THIS INFO WAS NOT PROVIDED BY THE COMPLETED QUES
CRITICAL CARE PSI PRODUCTS ARROW INTERNATIONAL INC:IT WAS REPORTED THAT THE PATIENT WAS BLEEDING FROM JUGULAR CATHETER, PRESSURE APPLIED AND DOCTOR NOT
CROSS LINKED HYALURONIC ACID AND LIDOCAINE INJECTA ANIKA THERAPEUTIC, INC.:THREE TO FOUR WEEKS POST INJECTION, THE PRODUCT EVOLVED INFO FIRM NODULES. THE NODULES ARE PALPABLE,
CROSS LINKED HYALURONIC ACID AND LIDOCAINE INJECTA ANIKA THERAPEUTICS, INC.:THREE TO SEVEN WEEKS POST INJECTION, THE LEFT SIDE (3-4 WEEKS) THEN THE RIGHT SIDE (6-7 WEEKS) DEVEL
CROSS LINKED HYALURONIC ACID WITH LIDOCAINE, 1ML ANIKA / COAPT:FOLLOWING USE OF HYDRELLE - FILLER PRODUCT - THREE PTS EXPERIENCED ADVERSE REACTIONS. COMPLAINT OF R
CRT-D BIOTRONIK SE & CO. KG:PER BIOTRONIK PT TRACKING, THIS DEVICE WAS EXPLANTED DUE TO POCKET DEHISCENCE WITH DEVICE EXPOSURE.
CRT-D BIOTRONIK SE & CO KG:DEVICE WAS REPORTED AS EOS VIA HOME MONITORING. NO KNOWN REASON FOR EOS ALERT. ONE MONTH AGO, THE DE
CRT-D BIOTRONIK SE & CO. KG:PER PT TRACKING, THIS SYSTEM WAS REMOVED DUE TO INFECTION AND, TO DATE, NO NEW SYSTEM HAS BEEN IMPLA
CRT-D BIOTRONIK SE & CO. KG.:PER BIOTRONIK PT TRACKING DEPT, THIS SYSTEM WS REMOVED DUE TO INFECTION. AT THIS TIME, THE SYSTEM HA
CRYOABLATION DEVICE AMERICAN MEDICAL SYSTEMS, INC.:UPON ARRIVAL, GMC PRESS=53, PCC PRESS=75, PASSED PRECOOL. THERMAL SWITCH ON FRONT HANDLE CAME UNGLUE
CRYOSPRAY CSA MEDICAL INC.:PT WAS CRITICALLY ILL SECONDARY TO METASTATIC LUNG DISEASE AND CORONARY ARTERY DISEASE. BRONCHOSCOPI
CT GE HEALTHCARE:STAFF WERE IN THE PROCESS OF PREPARING TO PERFORM CT STUDY ON PATIENT. CT-TUBE MALFUNCTIONED, CAUSIN
CT POWER INJECTOR SYSTEM LIEBEL-FLARSHEIM CO:PENDING INVESTIGATION. UPON RECEIPT OF THE INVESTIGATION REPORT, A MEDWATCH 3500A SUPPLEMENTAL REPOR
CT POWER INJECTOR SYSTEM LIEBEL-FLARSHEIM CO.:CUSTOMER REPORTS VIA PHONE, (B) (6) MALE HAVING A CT OF THE ABDOMEN WITH CONTRAST. IV ACCESS, RT AC
CT SCAN TOSHIBA:DEAR DR. (B) (6), MY NAME IS (B) (6), AND I WAS GIVEN FIVE CT-SCANS IN A PERIOD OF SIX MONTHS, AND E
CT SCANNER SIEMENS MEDICAL SOLUTIONS USA, INC.:IN THE MIDDLE OF SCANNING THIS PATIENT, THE SCANNER STOPPED MID-SCAN AND WOULD NOT COME BACK ON. APP
CT SCANNER TOSHIBA:(B) (6), I AM BEGGING OF YOU TO LOOK INTO THIS CT-SCAN ABUSE ISSUE GOING WITH THE (B)(6) AT THIS PAR
CUFF WITH IZ, 4.5 CM. AMS:THE PT UNDERWENT AN ARTIFICIAL URINARY SPHINCTER PLACEMENT. POSTOPERATIVELY, THE PT DEVELOPED URINA
CUP, URINE COLLECTION BD:WE ARE REPORTING TWO INCIDENTS WITH THIS REPORT. IN BOTH CASES, PATIENTS WERE INJURED WHEN USING THE
CUP/JDH SMITH & NEPHEW ORTHOPAEDICS AG:THE REVISION SURGERY WAS REPORTED DUE TO LOOSENING.
CURLIN 4000 INFUSION PUMP CURLIN MEDICAL LLC:ON (B) (6) 2010, I WAS PREPARING FOR A SHOWER WHEN I QUICKLY REALIZED THAT THERE WAS AN ABUNDANT AMO
CURLIN 6000 CMS BRAUN:CURLIN 6000 CMS PUMP HOOKUP BEGAN IN THE (B) (6) CLINIC. UPON STARTING THE PUMP, IT OVERHEATED AND I
CURLIN IV TUBING ZEVEX INC.:CURLIN MEDICAL ADMINISTRATION SET IV TUBING REF 340-4128 LEAKED DURING PARENTERAL NUTRITION INFUSION
CURLIN PUMP MOOG MEDICAL MANUFACTURER:PT WAS UNDER HOSPICE CARE AND A CURLIN 4000 CM5 PUMP; (B) (4) WAS CONNECTED TO HER TO DISPENSE DILAU
CURVED BLADE SMITH & NEPHEW INC., ENDOSCOPY DIVISION:THERE WAS RUST ON THE TIP OF THE SYNOVATOR AND IT WAS JAMMED AND WOULD NOT WORK. IT DID NOT ENTER T
CURVED NEEDLE DELIVERY SYSTEM SMITH & NEPHEW:CURVED NEEDLE DELIVERY SYSTEM MISFIRED UPON USE. DATES OF USE: (B) (6) 2010. DIAGNOSIS OR REASON FOR
CURVED ROD - SPINE SYNTHES (USA):DEVICE AVAILABLE FOR EVAL: YES.
CURVED SHEARS ETHICON:HARMONIC CURVED SHEARS FAILED TO ACTIVATE WHEN PLUGGED INTO BASE. REMOVED FROM FIELD AND NEW SHEARS
CURVED TIP, 260 LENGTH COOK MEDICAL:[(B) (4)] LUNDERQUIST WIRE INADVERTENTLY PERFORATED LEFT VENTRICLE, WHICH WAS LATER REPAIRED. NOT AN
CUSTOM COMFORT NIGHT GUARD DENTEK ORAL CARE:I USED DENTEK'S CUSTOM COMFORT NIGHTGUARD. ON THE FIRST MORNING AFTER FIRST USE, WHEN I TOOK IT OUT
CUTTER ETHICON ENDO SURGERY INC.:ETHICON PROXIMATE LINEAR CUTTER FAILED DURING APPLICATION. NO FURTHER DETAILS AVAILABLE.
CUTTING BLOCK / JWH SMITH & NEPHEW, INC. BROOKS MANUFACTURING SITE:IT WAS REPORTED THAT THE FEMUR IMPLANT ROTATION WAS TOO EXTERNAL AND THE TIBIA WAS CUT VALGUS WHEN U
CUTTING BLOCK / JWH SMITH & NEPHEW, INC., BROOKS:DEVICE CURRENTLY UNDERGOING ANALYSIS.
CUTTING LOOP 24FR, .014 WIRE COOK UROLOGICAL:AN ESU (GENERATOR) WAS USED IN CONJUNCTION WITH A KARL STORZ POWER CORD, STORZ RESECTOSCOPE, AND STO
CUTTING LOOP ELECTRODE OMNITECH SYSTEMS INC.:PIECE OF CUTTING LOOP BROKE OFF INSIDE PT. SURGEON WAS UNABLE TO IMMEDIATELY RETRIEVE BROKEN PIECE.
D05984 MEDTRONIC XOMED INSTRUMENTS:ANY MISSING INFORMATION OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROV
DAILY WEAR SOFT CONTACT LENS CIBA VISION CORPORATION:AN OPTICIAN REPORTED ON 21 JAN 2010 THAT A PT EXPERIENCED AN EPITHELIAL REACTION ASSOCIATED WITH WEA
DBM BONE VOID FILLER CONTATNING HUMAN DEMINERALIZE CORIN USA:I AM HAVING NECK, SHOULDER AND LEFT ARM PAIN. I ALSO HAVE MIGRAINE AND SINUS HEADACHES, SWELLING OF
DBX DEMINERALIZED BONE 1CC MATRIX CORIN USA:I AM HAVING NECK, SHOULDER AND LEFT ARM PAIN. I ALSO HAVE MIGRAINE AND SINUS HEADACHES, SWELLING OF
DEEP BRAIN STIMULATOR MEDTRONIC:IRREVERSIBLE SHUT DOWN OF DEEP BRAIN STIMULATOR. DIAGNOSIS OR REASON FOR USE: ESSENTIAL TREMOR.
DEFIB/PACING ELECTRODES ZOLL MEDICAL CORP:COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PT, THE ELECTRODES WOULD NOT ADHERE TO T
DEFIBRILLATION LEAD ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION:THE LEAD WAS CAPPED DUE TO A LOW HV IMPEDANCE ANOMALY. RESULTS OF THE ICD ANALYSIS INDICATED LEAD AR
DEFIBRILLATION PADS COVIDIEN:IT WAS REPORTED TO COVIDIEN ON 12/23/2009 THAT A CUSTOMER HAD AN ISSUE WITH DEFIBRILLATION PADS. THE
DEFIBRILLATION/PACEMAKER ZOLL MEDICAL CORPORATION:ZOLL MEDICAL CORP HAS NOT RECEIVED THE DEVICE FOR EVAL, AND THIS COMPLAINT IS STILL UNDER INVESTIGAT
DEFIBRILLATOR ST JUDE:DURING DEFIBRILLATION TESTING, VENTRICULAR FIBRILLATION WAS INDUCED BY THE ST JUDE FIBBER. VENTRICUL
DEFIBRILLATOR ZOLL MEDICAL CORP:ZOLL MEDICAL CORP HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A F/U REPORT WHEN OUR INVESTIGATION
DEFIBRILLATOR ZOLL MEDICAL CORPORATION:ZOLL MEDICAL CORP HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVES
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, SORIN BIOMEDICA CRM S.R.L.:THE ICD INVOLVED IN THIS MDR REPORT WAS REPORTEDLY IMPLANTED 2 WEEKS BEFORE THE EVENT. DURING A FOLL
DEFIBRILLATOR, CRT MEDTRONIC:THE HISTORY AND PHYSICAL NOTES THE FOLLOWING: THE PATIENT HAD A BIVENTRICULAR ICD IMPLANTED 33 MONTH
DEFIBRILLATOR, CRT MEDTRONIC INC.:THE PATIENT HAS A HISTORY OF NONISCHEMIC DILATED CARDIOMYOPATHY WITH SEVERELY DEPRESSED LEFT VENTRIC
DEFIBRILLATOR, CRT MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT:THE PATIENT HAD AN UPGRADE TO A BIVENTRICULAR DEVICE THREE YEARS AGO DUE TO REDUCED EJECTION FRACTIO
DEFIBRILLATOR, EXTERNAL MEDTRONIC/PHYSIO-CONTROL INC.:WE HAVE APPROXIMATELY 206 LIFEPAK 20'S IN OUR FACILITY'S INVENTORY. WE HAVE REVIEWED ALL OF THE LIF
DEFIBRILLATOR, EXTERNAL PHILIPS MEDICAL SYSTEMS:THE OR STAFF REPORT THERE WAS A PATIENT IN THE OR FOR CHEST RE-EXPLORATION. AS THE CHEST WAS OPENED
DEFIBRILLATOR, EXTERNAL ZOLL:THE PATIENT WAS CARDIOVERTED X 3. #1. 120J 155.5 DELIVERED, #2 120J SELECTED 158.4 DELIVERED, 3RD S
DEFIBRILLATOR, EXTERNAL, SEMI-AUTOMATIC ZOLL MEDICAL CORP:DURING INFANT TRANSPORT TO ANOTHER MEDICAL FACILITY THE CLINICIAN NEEDED TO CARDIOVERT A NEONATAL PA
DEFIBRILLATOR, IMPLANTABLE MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT:THE PATIENT WAS ADMITTED FROM THE MD'S OFFICE WITH CONCERNS FOR INFECTED ICD POCKET SITE WITH EROSIO
DEFIBRILLATOR, M-SERIES ZOLL MEDICAL CORPORATION:WHILE PREPARING TO TRANSPORT PT WITH THE DEFIBRILLATOR, THE FOLLOWING ERROR MESSAGES FLASHED: SYSTEM
DEFIBRILLATOR/PACEMAKER ZOLL MEDICAL CORP:COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "DEFIB FAULT 78" MESSAGE. COM
DEFIBRILLATOR/PACEMAKER ZOLL MEDICAL CORPORATION:COMPLAINANT ALLEGED THAT THE DEVICE DISPLAYED A "BRIDGE TEST FAILED" MESSAGE. COMPLAINANT INDICATED
DELIVERY CATHETER EV3 NEUROVASCULAR:TREATMENT OF AN AVM WITH ONYX. IT WAS REPORTED FOLLOWING APPROX 40 MINUTES OF ONYX INJECTION, IT WAS
DELIVERY SYSTEM AGA MEDICAL CORPORATION:THE DTV45 SHEATH, DILATOR, LOADER AND DELIVERY CABLE WERE RECEIVED AT AGA MEDICAL AND THE DISTAL TIP
DELPHIN PUMP HEAD TERUMO CARDIOVASCULAR SYSTEMS:DURING THE PRIMING OF THE CARDIOPULMONARY BYPASS CIRCUIT, THE CENTRIFUGAL PUMP HEAD BROKE. THE FIN B
DENTAL ADHESIVE CREAM, ORIGINAL AND COMPLETE PROCTER & GAMBLE:I HAVE HAD AN UPPER RIGHT BRIDGE CONNECTED BY THREE TEETH FOR MORE THAN 20 YRS. DURING THAT TIME, I'
DENTAL CEMENT KERR CORPORATION:THE DOCTOR REPORTED THAT RESTORATIONS THAT HAD BEEN SEATED WITH NX3 DUAL CURE CEMENT CLEAR DE-BONDED
DENTAL HANDPIECE AND ACCESSORIES KAVO DENTAL GMBH:WHILE THE DENTIST WAS WORKING ON TOOTH # 28-31, THE CORNER OF THE PATIENT'S MOUTH WAS BURNED WHEN TH
DENTURE ADHESIVE PROCTOR & GAMBLE:I BEGAN USING POLIGRIP IN 1988. I NOTICED PROBLEMS WITH MY HANDS AND ARMS GRADUALLY IN 1988 AND ASSU
DENTURE CREAM UNK:DOCTOR HAS DIAGNOSED ME WITH NEUROPATHY IN MY LEGS, PROBABLY DUE TO USING FIXODENT DENTURE CREAM FOR
DERMACARRIERS 1.5 TO 1 ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS:IT WAS REPORTED THAT THE ZIMMER DERMACARRIER II SHREDDED THE GRAFT MAKING IT UNUSABLE. ADD'L SKIN HA
DERMAL FILLER BIOFORM MEDICAL:PT WAS INJECTED IN THE NASOLABIAL FOLDS AND CHEEKS WITH RADIESSE DERMAL FILLER; SHE THEN DEVELOPED T
DERMAL FILLER BIOFORM MEDICAL, INC.:THE PT TREATED HIMSELF WITH AUGMENTIN AND PREDNISONE; THE INFECTION HAS RESOLVED, BUT HE STATES HE H
DERMATOME ZIMMER, INC:A PADGETT BLADE WAS PLACED IN A ZIMMER DERMATOME. IT SEEMINGLY FIT WELL. WHEN THE DEVICE WAS USED, T
DETACHABLE COIL EV3 NEUROVASCULAR:THE DEVICE WAS RETURNED FOR EVALUATION AND THE IMPLANT COIL WAS FOUND DETACHED. THE PUSHER ASSEMBLY
DETACHATIP MULTI-USE LAPAROSCOPIC INSTRUMENT, GRAS CONMED CORPORATION:THE PATIENT WAS ADMITTED FOR A LAPAROSCOPIC REPAIR RIGHT INGUINAL HERNIA, WHICH PROCEEDED TO CONCLUS
DETECTOR AND ALARM, ARRHYTHMIA LIFEWATCH SERVICES INC:ASSOCIATED ACCESSORY DEVICE: MONITOR, MODEL # COM001, (B) (4).
DEVICE, ELECTROCONVULSIVE THERAPY SOMATICS LLC:PATIENT UNDERGOING ECT TREATMENT FOR BIPOLAR DISORDER. THE SKIN OF THE POST-AURICULAR, FOREHEAD, AN
DEVICE, HEMOSTASIS, VASCULAR ABBOTT VASCULAR, INC.:AFTER RETURNING THE LEVER BACK DOWN TO PARK THE FOOT, RESISTANCE WAS ENCOUNTERED IN REMOVING THE PER
DEVICE, INTRACRANIAL PRESSURE MONITORING CODMAN & SHURTLEFF, INC:REP REPORTED THAT THE DEVICE WAS IMPLANTED ON 2/23 AND INITIALLY EVERYTHING WORKED FINE. SEVERAL HOU
DEVICE, INTRACRANIAL PRESSURE MONITORING CODMAN & SHURTLEFF, INC.:UPON COMPLETION OF THE INVESTIGATION, A F/U REPORT WILL BE FILED.
DEVICE, INTRACRANIAL PRESSURE MONITORING CODMAN & SHURTLEFF, INC. MEDOS S.A:REP REPORTED THAT THE MICROSENSOR THAT WAS USED ON A PT BROKE OFF. IT WAS EXPLANTED THAT THE SENSOR
DEVICE, INTRACRANIAL PRESSURE MONITORING CODMAN & SHURTLEFF, INC., MEDOS S.A.:UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.
DEVICE, IRRIGATION, OCULAR SURGERY ALCON RESEARCH, LTD.:A 25 G POSTERIOR VITRECTOMY WAS SURGICAL PROCEDURE TO BE PERFORMED USING THE ALCON ACCURUS 25 G TUBI
DEVICE, MONITORING, INTRACRANIAL PRESSURE INTEGRA NEURO SCIENCES:THE CABLE WAS BROKEN WHEN IT WAS REMOVED FROM THE PACKAGE AND THE DOCTOR WAS NOT EVER ABLE TO OBTAIN
DEVICE, NEUROVASCULAR EMBOLIZATION BOSTON SCIENTIFIC:THIS PATIENT UNDERWENT AN EMBOLIZATION OF A BRAIN ANEURYSM. DURING THE PROCEDURE THE PHYSICIAN MET
DEVICE, NEUROVASCULAR EMBOLIZATION BOSTON SCIENTIFIC - CORK:APPROXIMATELY SEVEN MONTHS AFTER THE COIL EMBOLIZATION OF THE ANEURYSM, THE PATIENT UNDERWENT A SECO
DEVICE, NEUROVASCULAR EMBOLIZATION BOSTON SCIENTIFIC - FREMONT:FOLLOWING THE SUCCESSFUL COIL EMBOLIZATION OF THE LEFT PARACLINOID/OPHTHALMIC ARTERY ANEURYSM, THE P
DEVICE, NEUROVASCULAR EMBOLIZATION BOSTON SCIENTIFIC - MAPLE GROVE:DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATIO
DEVICE, NEUROVASCULAR EMBOLIZATION BOSTON SCIENTIFIC CORPORATION:THE COIL WAS BEING PLACED IN A PARAOPHTHALMIC ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY (
DEVICE, NEUROVASCULAR EMBOLIZATION BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVIS:THE PT UNDERWENT THE SUCCESSFUL STENT ASSISTED COIL EMBOLIZATION OF A SIDEWALL MIDDLE CEREBRAL ARTER
DEVICE, NEUROVASCULAR EMBOLIZATION NEUROVASCUALR DIVISION, BOSTON SCIENTIFIC CORP.:CONCLUSION: ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE F
DEVICE, NEUROVASCULAR EMBOLIZATION NEUROVASCULAR DIV, BOSTON SCIENTIFIC CORP.:THE PATIENT PRESENTED WITH A SUBARACHNOID HEMORRHAGE (SAH) AND HAD A SACCULAR ANEURYSM ON THE ANTERI
DEVICE, NEUROVASCULAR EMBOLIZATION NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP:ONE DAY AFTER A SECOND PROCEDURE TO COIL EMBOLIZE THE LEFT INTERNAL CAROTID ARTERY ANEURYSM, THE PAT
DEVICE, NEUROVASCULAR EMBOLIZATION NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.:CONCLUSION: ANTICIPATED PROCEDURAL COMPLICATION.A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DE
DEVICE, THERMAL ABLATION, ENDOMETRIAL BOSTON SCIENTIFIC - MARLBOROUGH:THE DEVICE HAS NOT BEEN RETURNED SINCE IT WAS DISPOSED OF; THEREFORE A FAILURE ANALYSIS OF THE COMPL
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION BOSTON SCIENTIFIC - CORK:(B) (4). (B) (4).
DEXCOM7 DEXCOM, INC.:DEXCOM CONTINUOUS GLUCOSE MONITOR. I PURCHASED THE DEXCOM CONTINUOUS BLOOD GLUCOSE MONITOR AND I HAV
DHS/DCS PLATES SYNTHES MONUMENT:DHS/DCS LAG SCREW IMPLANTED FOR APPROXIMATELY 12 MONTHS BROKE IN THE BARREL OF THE PLATE. PATIENT PR
DIABETES METER ABBOTT DIABETES CARE:USED A SUGAR TESTING DEVICE THAT SHOWED 3 DIFFERENT READINGS IN LESS THAN 2 MINUTES OF TIME, FROM TH
DIAGNOSTIC E.P. CATHETER BIOSENSE-WEBSTER J&J CO.:DIAGNOSTIC CATHETER ADVANCED THRU LONG SHEATH INTO PATIENT'S LEFT ATRIUM; REMOVED AND SET ASIDE. ON
DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO) CORDIS DE MEXICO:THE PRODUCT HAS BEEN RETURNED FOR EVALUATION, BUT THE ANALYSIS IS NOT YET COMPLETE. A PRELIMINARY AN
DIAGNOSTIC ULTRASOUND SYSTEM PHILIPS ULTRASOUND:A 3D TEE PROBE WAS USED TO MONITOR PT DURING CABG SURGERY. SEVERAL DAYS LATER, IT WAS REPORTED THAT
DIALYSIS CATHETER EXTENDER COVIDIEN:(B) (4). AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
DIALYSIS SOLUTION FOR CONTINUOUS RENAL REPLACEMENT GAMBRO:PRISMASATE BGK2/0 DIALYSIS SOLUTION FOR CONTINUOUS RENAL REPLACEMENT THERAPY 5000 ML BAG, GAMBRO CAT
DIALYZER FRESENIUS:THE DIALYSIS NURSE NOTICED BLOOD LEAKING FROM THE BOTTOM OF THE DIALYZER AROUND THE BLUE SEAL. THER
DIALYZER OGDEN MANUFACTURING:IT IS THE BELIEF OF FMC NA THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. SAMPLE WAS NOT
DIALYZER (NON-REUSE) ASAHI:TREATMENT STARTED, PT COMPLAINT OF FEELING HOT, FLUSHED THROBBING SENSATION IN HEAD, GIVEN 300CC NS,
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED BAXTER HEALTHCARE - CLEVELAND:BAXTER'S CHIEF EXECUTIVE OFFICER RECEIVED A LETTER FROM A HOME PATIENT (HP) INDICATING THAT OVER THE
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED NIPRO CORPORATION *USD*:THIS COMPLAINT ORIGINATED AS A RESULT OF THE BAXTER RENAL CLINICAL HELPLINE SPECIALIST FORWARDING A
DIAMOND BLADE UNK:PATIENT HAD RADIAL KERATOMY PERFORMED (B) (6). IN THE LAST 2-3 YEARS, PATIENT HAS BEEN EXPERIENCING
DILATOR CARDINAL HEALTH:OUTPATIENT LAPAROSCOPY PERFORMED AT OUTPATIENT FACILITY. AFTER THE PROCEDURE, WHEN THE DILATOR THAT
DILATOR COOK MEDICAL INC.:THE PATIENT WAS ADMITTED FOR A RIGHT LEG ANGIOPLASTY DUE TO SEVERE CALCIFICATION. A ONE AND ONE-HALF
DIODE RH USA, INC.:AN EVALUATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL SPECIALIST CONCLUDED THE ROOT CAUSE OF TH
DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER BECKMAN COULTER INC.:QC WAS WITHIN CUSTOMER'S ESTABLISHED RANGES. A SYSTEM CHECK PERFORMED ON 01/15/2010 WAS WITHIN SPECI
DISINFECTANT, MEDICAL DEVICES METREX RESEARCH CORPORATION:ON JANUARY 19, 2010, A COMPLAINANT REPORTED THAT AFTER CAVICIDE WAS SPRAYED ONTO A COUNTERTOP, SHE A
DISINFECTION SYSTEM, FLEXIBLE SCOPE STERIS:PEDIATRIC FLEXIBLE BRONCHOSCOPES (BOTH OLYMPUS, MODEL # BFXP160F), DURING PRE-USE AND CLEANING INSPE
DISLODGER, STONE, BASKET, URETERAL, METAL BOSTON SCIENTIFIC - SPENCER:NOTE: THIS EVENT, AS REPORTED, DID NOT REFLECT AN MDR REPORTABLE SCENARIO; HOWEVER, EVALUATION OF TH
DISPERSIVE ELECTRODE CONMED CORP.:THE QUALITY DEPARTMENT WAS MADE AWARE OF THIS INCIDENT ON DAY 30 FROM THE FIRST DATE, A CONMED EMPLO
DISPERSIVE ELECTRODE CONMED CORPORATION:THE ACTUAL DEVICE WILL NOT BE RETURNED. WHEN THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WI
DISPERSIVE ELECTRODE CONSOLIDATED MEDICAL EQUIPMENT COMPANY:IT WAS REPORTED "PT COMPLAINED OF LEFT CALF PAIN IN RECOVERY ROOM. TWO INCH IN DIAMETER REDDENED ARE
DISPOSABLE CLIP APPLIER PONCE - USS:.
DISPOSABLE CLIP APPLIER PONCE- USS:ACCORDING TO THE REPORTER, SEVERAL CLIPS SCISSORED DURING THE PROCEDURE, AND THE CLIPS FAILED TO LOA
DISPOSABLE CLIP APPLIER UNITED STATES SURGICAL:(B) (4). (B) (4).
DISPOSABLE HOSPITAL LANCET ROCHE DIAGNOSTICS:(B) (4). (B) (4).
DISPOSABLE PRESSURE MONITOR EDWARDS LIFESCIENCES:AS REPORTED: KIT HAD BEEN IN SITU FOR 48 HOURS WITH NO PROBLEMS IN (B) (6) BOY. PATIENT HAD BEEN STA
DISPOSABLE PRESSURE TRANSDUCER SMITHS MEDICAL ASD, INC.:NURSE FOUND SYRINGE WOULD NOT FLUSH.
DISPOSABLE STAPLER NORTH HAVEN - USS:PROCEDURE: ROUX-EN-Y. ACCORDING TO THE REPORTER: THE DEVICE WOULD NOT FIRE COMPLETELY. THERE WAS BLE
DISPOSABLE STAPLER NORTH HAVEN- USS:PROCEDURE: LOBECTOMY. ACCORDING TO THE REPORTER: USED ON BIFURCATED PART ON BRONCHIAL TUBES. AFTER F
DISPOSABLE STAPLER NORTH HAVEN-USS:(B) (4).
DISPOSABLE STAPLER PONCE - USS:PROCEDURE: VATS. ACCORDING TO THE REPORTER: THE SULU DID NOT FIRE COMPLETELY. THE PROCEDURE WAS PROL
DISPOSABLE STAPLER PONCE- USS:(B) (4).
DISPOSABLE STAPLER UNITED STATES SURGICAL:PROCEDURE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE SURGEON WAS CREATING THE SMALL GASTRIC POU
DISPOSABLE STAPLER UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC:(B) (4)
DISPOSABLE STAPLER UNITES STATES SURGICAL:ACCORDING TO AN ARTICLE PUBLISHED ON OBES SURG 19:821-826 (2009) TITLED "NONSURGICAL TREATMENT OF ST
DISPOSABLE STAPLER USSC PUERTO RICO:PROCEDURE: LOBECTOMY. ACCORDING TO THE REPORTER: THE INSTRUMENT JAMMED ON TISSUE. THE SURGEON WAS AB
DISPOSABLE STAPLER USSC PUERTO RICO, INC.:(B) (4). (B) (4).
DISPOSABLE SURGICAL ACCESS DEVICE NORTH HAVEN - USS:(B) (4). (B) (4).
DISPOSABLE SURGICAL ACCESS DEVICE NORTH HAVEN- USS:(B) (4). (B) (4).
DISPOSABLE SURGICAL ACCESS DEVICE PONCE - USS:.
DISPOSABLE SURGICAL ACCESS DEVICE PONCE- USS:PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: DEVICE FAILED TO FIRE TACKS, AFTER FIRST TACK DEP
DISPOSABLE SURGICAL ACCESS DEVICE PONCE-USS:PROCEDURE TYPE: PNEUMONECTOMY. ACCORDING TO THE REPORTER: THE JAWS OF THE STAPLER WERE CLOSED, BUT T
DISPOSABLE SURGICAL ACCESS DEVICE USSC PUERTO RICO:(B) (4). (B) (4).
DISPOSABLE SURGICAL ACCESS DRIVE USSC PUERTO RICO:(B) (4)
DISPOSABLE SURGICAL ACCESSORY NORTH HAVEN - USS:.
DISPOSABLE SURGICAL ACCESSORY PONCE - USS:(B) (4).
DISPOSABLE SURGICAL CLIP APPLIER NORTH HAVEN - USS:(B) (4). (B) (4).
DISPOSABLE SURGICAL CLIP APPLIER PONCE - USS:PROCEDURE: HYSTERECTOMY. ACCORDING TO THE REPORTER: THE PT HAD A TOTAL ABDOMINAL HYSTERECTOMY, AMONG
DISPOSABLE SURGICAL DEVICE USSC PUERTO RICO:PROCEDURE: LAP-SCOPI. ACCORDING TO THE REPORTER: THE SURGEON ENCOUNTERED SOME RESISTANCE WHILE INSER
DISPOSABLE SURGICAL STAPLER NORTH HAVEN - USS:(B) (4).
DISPOSABLE SURGICAL STAPLER NORTH HAVEN - USS:.
DISPOSABLE SURGICAL STAPLER NORTH HAVEN-USS:.
DISPOSABLE SURGICAL STAPLER PONCE - USS:PROCEDURE: COLON RESECTION. ACCORDING TO THE REPORT: THE SURGEON USED THE PCEEA IN THIS CASE, AND TH
DISPOSABLE SURGICAL STAPLER PONCE-USS:(B) (4). (B) (4). THIS REPORTED LOT NUMBER IS SUBJECT TO THE RECALL INITIATED ON FEBRUARY 8, 2010. T
DISPOSABLE SURGICAL STAPLER UNITED STATES SURGICAL:PROCEDURE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER, THE PATIENT HAD A DISTAL TRANSECTION P
DISPOSABLE SURGICAL STAPLER UNITED STATES SURGICAL A:(B) (4).
DISPOSABLE SURGICAL STAPLER USSC PUERTO RICO:(B) (4). (B) (4). PRODUCT NOT RELEASED FOR USE IN THE UNITED STATES -NO 510K.
DISPOSABLE SURGICAL STAPLER USSC PUERTO RICO, INC.:PROCEDURE TYPE: COLOSTOMY TAKEDOWN. ACCORDING TO THE REPORTER: THE ANVIL WAS PLACED WITH PURSESTRING
DISPOSABLE SURGICAL TACK APPLER PONCE- USS:(B) (4).
DISPOSABLE SURGICAL TACK APPLIER PONCE - USS:(B) (4). (B) (4). THIS REPORTED LOT NUMBER IS SUBJECT TO THE RECALL INITIATED (B) (4), 2010.
DISPOSABLE SURGICAL TACK APPLIER PONCE -USS:(B) (4). (B) (4). THIS REPORTED LOT NUMBER IS SUBJECT TO THE RECALL INITIATED FEB 8, 2010. THEREFORE
DISPOSABLE SURGICAL TACK APPLIER PONCE- USS:PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: TRIGGER LOCKED WHEN HANDLE WAS SQUEEZED; WOULD NO
DISPOSABLE SURGICAL TACK APPLIER PONCE-USS:(B) (4). (B) (4). THIS REPORTED LOT NUMBER IS SUBJECT TO THE RECALL INITIATED FEBRUARY 8, 2010. THER
DISPOSABLE SUTURING DEVICE NORTH HAVEN - USS:(B) (4).
DISPOSABLE SUTURING DEVICE NOTH HAVEN - USS:PROCEDURE TYPE: HYSTERECTOMY. ACCORDING TO THE REPORTER: THE NEEDLE BROKE OFF IN THE ABDOMEN DURING
DISPOSABLE SUTURING DEVICE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC:(B) (4)
DISPOSABLES MEDTRONIC MINIMED:CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO
DISPOSABLES MEDTRONIC PUERTO RICO OPERATIONS MED-REL:CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRO
DISSECTION TIP MAQUET CARDIOVASCULAR LLC:THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE CONICAL TIP (DISTAL END)
DISSECTION TIP MAQUET CARDIOVASCULAR, LLC:THE DEVICE WAS RETURNED TO CARDIAC SURGERY ON 20 JAN 2010 FOR INVESTIGATION. A SUPPLEMENTAL REPORT W
DISSECTION TIP FROM VV HEMOPRO MAQUET CARDIOVASCULAR:THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE DISSECTION TIP FROM A
DISSECTION TIP FROM VV HEMOPRO MAQUET PUERTO RICO, LLC:MAQUET CARDIOVASCULAR RECEIVED THE DEVICE ON 01/05/2009. QUALITY WILL EVALUATE THE DEVICE AND PERFOR
DISSECTION TIP FROM VV HEMOPRO-OUS MAQUET PUERTO RICO B.V.:THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE DISSECTION TIP OF THE
DISSECTION TIP FROM VV HEMOPRO-OUS MAQUET PUERTO RICO, LLC:MAQUET CARDIOVASCULAR RECEIVED THE DEVICE ON 01/13/2010. QUALITY WILL EVALUATE THE DEVICE AND PERFOR
DISSECTION TIP FROM VV6 MAQUET PUERTO RICO, LLC:THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE DISSECTION CONE FROM
DISTAL FEMUR PLATES SYNTHES MONUMENT:A PATIENT WAS IMPLANTED WITH A TI DISTAL FEMUR LISS PLATE APPROXIMATELY 5 MONTHS AGO. PATIENT WAS NO
DISTRACTOR KARL LEIBINGER GMBH U CO. KG:DR (B) (6) AT (B) (6) HOSPITAL EXPLANTED A 51-424-30 MICRO-ZURICH DISTRACTOR FROM A (B) (6) BOY, DUE
DISTRACTOR KARL LEIBINGER GMBH U. CO. KG:A DR AT THE HOSPITAL EXPLANTED (THREE WEEKS AFTER IMPLANT) A 51-430-20 MICRO-ZURICH 20 MM, END DRIVE
DO3517 MEDTRONIC XOMED INSTRUMENTS:ANY MISSING INFO OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFO NOT BEING PROVIDED OR RELEAS
DOPPLER PARKS:THIS UNIT BEGAN TO SMOKE AFTER POWER UP. WAS NOT BEING ON A PT AT TIME OF INCIDENT.
DQK COMPUTER, DIAGNOSTIC, PROGRAMMABLE BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL):BIOSENSE WEBSTER, INC. PROFESSIONAL EDUCATION SPECIALIST (PES), WHO WAS ON-SITE DURING ABLATION PROC
DQK COMPUTER, DIAGNOSTIC, PROGRAMMABLE BIOSENSE WEBSTER, LTD. (HAIFA, ISRAEL):INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED ONC
DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC COOK, INC.:THE PHYSICIAN REPORTED THAT DISSECTIONS HAVE BEEN EXPERIENCED IN THE LAST THREE CASES, WHICH IS BELI
DQR CANNULA, CATHETER COOK, INC.:PT HAD A LEFT SIDED PLEURAL EFFUSION - DRAIN WAS INSERTED AND IMMEDIATELY DRAINED 850MLS OF BLOOD. C
DQX WIRE, GUIDE, CATHETER BOSTON SCIENTIFIC:IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS O
DQX WIRE, GUIDE, CATHETER COOK, INC.:THE RADIOPAQUE OBJECT WAS DISCOVERED AT THE END OF THE CATH LAB PROCEDURE. OBJECT SEEMS TO BE A META
DQY / LIT BARD PERIPHERAL VASCULAR, INC.:THE LOT NUMBER HAS BEEN PROVIDED AND A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFO
DQY CATHETER, PERCUTANEOUS BOSTON SCIENTIFIC:SAME CASE AS: 2134265-2010-00299 AND 2134265-2010-00296. IT WAS REPORTED THAT DURING A CORONARY STEN
DQY CATHETER, PERCUTANEOUS BOSTON SCIENTIFIC CORPORATION:IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS O
DQY CATHETER, PERCUTANEOUS COOK INC:THE DEVICES WERE IMPLANTED WITHOUT PROBLEM. INTRA-ANGIO REVEALED A PROXIMAL TYPE 1 ENDOLEAK. THEY RE
DQY CATHETER, PERCUTANEOUS COOK, INC.:AN EXAMINATION OF THE RETURNED USED AND DAMAGED DEVICE, FOUND THE BALLOON WAS CIRCUMFERENTIALLY TORN
DQY/CATHETER, PERCUTANEOUS W.L. GORE & ASSOCIATES:A REVIEW OF THE MANUFACTURING RECORDS IS BEING CONDUCTED. IMAGES HAVE BEEN REQUESTED.
DRAIN, WOUND CARDINAL HEALTH:WHEN THE PHYSICIAN REMOVED THE HEMOVAC DRAIN FROM THE PATIENT'S KNEE IT WAS NOTICED THAT THE TIP HAD
DRAINABLE POUCH WITH CLAMP-2 PIECE OSTONY SYSTEM HOLLISTER, INC. (HOLLISTER):POUCH POPS OFF FACEPLATE, WONT STAY ON. MANUFACTURER MUST HAVE REALIZED THIS PRODUCT WAS FAULTY WHEN
DRAPE, SLUSH OR SOLUTIONS:SLUSH DRAPE BEGAN LEAKING WHEN ICE/WATER WAS ADDED.
DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATIO COOK, INC.:(B) (4). EVENT IS STILL UNDER INVESTIGATION AT THIS TIME.
DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZAT COOK, INC.:(B) (4). VESSEL DILATORS ARE INSPECTED TO ENSURE THE GLUED TWO PART FITTINGS: FLARE MUST BE SECURELY
DREAM MACHINE FRESENIUS MED CARE:PT EXPERIENCED ABDOMINAL/CHEST PAIN/PAIN RADIATING TO SHOULDER WHILE DIALYZING AT NIGHT ON THE LIBER
DRESSING, GAUZE MEDLINE INDUSTRIES, INC.:THE GAUZE HAD BEEN SOAKED IN DAKINS SOLUTION AND WAS BEING APPLIED TO AN OPEN WOUND USING STERILE TE
DRF CATHETER, ELECTRODE RECORDING BIOSENSE WEBSTER, INC. (IRWINDALE):UPON MULTIPLE REQUESTS, BWI HAS NOT OBTAINED ANY NEW INFORMATION IN REGARDS TO THIS CASE. IF THE PRO
DRF CATHETER, ELECTRODE RECORDING BIOSENSE WEBSTER, INC. (JUAREZ):(B) (4). TWO ST. JUDE MEDICAL TRANSSEPTAL SHEATHS AND NEEDLES WERE ALSO USED DURING THE PROCEDURE. A
DRF CATHETER, ELECTRODE RECORDING, OR PROBE ELECTR BIOSENSE WEBSTER, INC. (IRWINDALE):THE CATHETER WAS DISCARDED BY THE FACILITY/ NOT RETURNED FOR INVESTIGATION. THE BIOSENSE WEBSTER FIE
DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT BIOSENSE WEBSTER, INC. (IRWINDALE):IT WAS REPORTED WHILE PERFORMING AN AFIB ABLATION, WITH GENERATOR SETTING AT 30 WATTS, ON THE ANTERI
DRF CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR BIOSENSE WEBSTER, INC. (IRWINDALE):IT WAS REPORTED THAT TOWARDS THE END OF THE AF CASE, A STEADY DECREASE IN THE PT'S BLOOD PRESSURE WA
DRF RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCES STOCKERT GMBH:THE CUSTOMER STATED THAT THE INCIDENT WAS NOT CAUSED BY ANY OF BWI EQUIPMENT. INVESTIGATION IS STILL
DRILL STRYKER INSTRUMENTS:PT WITH FRACTURED LEFT HUMERUS AND WAS UNDERGOING AN OPEN REDUCTION WITH INTERNAL FIXATION OF THE LE
DRILL BIT DEPUY ORTHOPAEDICS, INC.:WHEN THE SURGEON WAS DRILLING INTO THE FEMORAL BONE DURING THE TOTAL KNEE REPLACEMENT, THE STAINLESS
DRILL BIT SYNTHES TRAUMA SUPPLIES:PT WITH FOUR-PART LEFT PROXIMAL HUMERUS FRACTURE AFTER SKIING ACCIDENT. SURGERY PLANNED WAS OPEN RED
DRILL BIT, ORTHOPEDIC SYNTHES (USA) PRODUCTS LLC:A (B) (6) MALE WHO UNDERWENT SURGERY FOR A RIGHT DISTAL HUMERUS FRACTURE WITH INTERNAL FIXATION, A R
DRILL GUIDE SYNTHES (USA) LLC:DURING THE PROCEDURE, THE DRILL GUIDE TIP BROKE OFF WHILE IN USE. THERE WAS ONLY A SINGLE PIECE AND
DRILLS, BURRS, TREPHINES & ACC CODMAN & SHURTLEFF, INC.:REP REPORTED THAT THE PERFORATOR BECAME "STUCK" IN THE PATIENT'S HEAD. IT WAS NOTED THAT THE DEVICE
DRILLS, BURRS, TREPHINES & ACC. CODMAN & SHURTLEFF, INC.:AFFILIATE REPORTED THAT THE SURGEON EXPLAINED THAT THE DEVICE FUNCTIONED AS NORMAL AND THAT HE FELT
DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, MEDTRONIC SOFAMOR DANEK USA, INC:PATIENT UNDERGOING A CRANIOTOMY FOR A SUBDURAL HEMATOMA, AND RESECTION OF A BRAIN TUMOR. DURING THE
DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, PO MEDTRONIC:THE MD WAS USING THE DISSECTING ROUTER WHEN THE DRILL BIT DROVE STRAIGHT THROUGH THE FOOT PLATE AND
DRILLS, BURS, TREPHINES & ACCESSORIES STRYKER IRELAND LTD.:IT WAS REPORTED DURING A CRANIAL PROCEDURE, THE PERFORATOR BIT TORE THE DURAL WITH SOME DAMAGE TO TH
DRIVE SHAFT SYNTHES MONUMENT:PATIENT UNDERWENT AN INTRAMEDULLARY GRAFT HARVEST WITH RIA SYSTEM THROUGH A RETROGRADE FEMORAL APPRO
DRUG ELUTING STENT ABBOTT VASCULAR:PROMUS STENT UNABLE TO CROSS THE LESION WHILE PULLED BACK STENT CAME OFF THE BALLOON. THE LOOSE STEN
DRUG ELUTING STENT (NIQ) BOSTON SCIENTIFIC (BOSTSCIEE):TWO STENTS PLACED MID RCA. PT EXPERIENCED BLOOD CLOT IMMEDIATELY. PT WAS STABILIZED. PT IS EXPERIENC
DRUG-ELUTING (NIQ) CORDIS LLC (PR):THE REPORT IS FROM THE (B) (6) STUDY. THE PT IS A (B) (6) YEAR OLD (B) (6) FEMALE WITH A HISTORY OF
DRUG-ELUTING STENT (NIQ) CORDIS DE MEXICO:DURING A CORONARY INTERVENTION, A 2.25 X 18MM CYPHER SELECT + BURST BETWEEN 8-10 ATMOSPHERES. ANOTHE
DRUG-ELUTING STENT (NIQ) CORDIS LLC:THE INFORMATION RECEIVED INDICATED THAT A HOSPITAL PROFESSIONAL CALLED ON BEHALF OF THE PATIENT'S DA
DRUG-ELUTING STENT (NIQ) CORDIS LLC (PR):SIX YEARS AFTER HAVING A CYPHER STENT IMPLANTED, THE PT EXPIRED FROM AN UNK CAUSE. THE REPORT RECEIV
DSI, DRT PHILIPS MEDICAL SYSTEMS:THE CUSTOMER REPORTED THAT A PATIENT EXPERIENCED A BRADY EVENT BUT THAT THE ALARM DID NOT SOUND.
DSY / PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREAT W.L. GORE & ASSOCIATES:DEVICE LOT NUMBER WAS NOT AVAILABLE. DEVICE MFG RECORD WAS NOT COMPLETED. DEVICE WAS NOT RETURNED TO
DSY, LJS, MSD HEMOSPHERE INC.:THE EVENT WAS ORIGINALLY EVALUATED AND DEEMED NOT REPORTABLE BASED ON THE INFO THAT OUR DEVICE WAS A
DSY/PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER W.L. GORE & ASSOCIATES:ON (B) (6) 2008, A NEW GORE PROPATEN VASCULAR GRAFT WAS IMPLANTED IN AN A-V ACCESS PROCEDURE IN THE
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR COOK, INC.:IVC FILTER PLACEMENT IN 2009. IT WAS FIRST DISCOVERED TO HAVE MIGRATED THREE MONTHS LATER, BASED ON
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR WILLIAM COOK EUROPE:THIS EVENT IS STILL UNDER INVESTIGATION.
DUAL CHANNEL IV PUMP BAXTER HEALTHCARE:HEPARIN WAS PRESCRIBED FOR INFUSION AT A RATE OF 23 ML/HR UTILIZING CHANNEL #1 OF A BAXTER FLO-GARD
DUEAL LUMEN DIALYSIS CATHETER MEDCOMP:DIALYSIS CATHETER NOT FUNCTIONING. CATHETER BEING REMOVED IN SURGERY. WHILE REMOVING CATHETER FROM B
DURA SUBSTITUTE CODMAN & SHURTLEFF, INC.:REP REPORTED THAT A COUPLE OF WEEKS AFTER THE PROCEDURE, THE PT WAS DIAGNOSED WITH CHEMICAL MENINGIT
DURAL SEALANT NQR CONFLUENT SURGICAL, INC:SWELLING OF THE DURASEAL IS A NORMAL CONDITION. THE CURRENT DURASEAL IFU FOR DSD5005, ITEM LCN 80-20
DURAL SEALANT NQR CONFLUENT SURGICAL, INC.:ACCORDING TO THE REPORTER, ONE MONTH AFTER USING THE DURASEAL PRODUCT IN CLOSURE OF A DURA MATER, TH
DURAL SEALANT NQR CONFLUENT SURGICAL,INC:ON 01/14/2010, THE SURGEON REPORTED THAT "THE PATIENT'S PROGNOSIS IS FAIR. SHE HAS RESIDUAL DEFECTS
DURASEAL COVIDIEN:DURASEAL SOLUTION FAILED TO MIX.
DURATA LEAD ST JUDE MEDICAL:PT HAD RECENT REIMPLANTATION OF THE AUTOMATIC IMPLANTABLE CARDIAC DEFIBRILLATOR IN 2009, WHEN IT WAS
DUROM ACETAB. COMP. 58/52 CODE ZIMMER GMBH:(B) (4). CONCLUSION: NO PRODUCT WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS WA
DUROM ACETABULAR COMONENT AND METASUL LDH LA ZIMMER GMBH:INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC. ((B) (4)), WHICH MARKETS THE DEV
DUROM ACETABULAR COMPONENT ZIMMER GMBH:INFORMATION WAS FORWARDED FROM ZIMMER INC WHICH MARKETS THE DEVICES IN THE U.S. NO PRODUCT WAS RETUR
DUROM ACETABULAR COMPONENT 54/48 CODE N ZIMMER GMBH:(B) (4). CONCLUSION: THE QUALITY RECORDS INDICATE THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, MEAS
DUROM ACETABULAR COMPONENT AND METASUL ZIMMER GMBH:CONCLUSION: THE INVESTIGATION SHOWS THAT THERE IS NO SIGN OF A MATERIAL OR PRODUCTION FAILURE. THIS
DUROM ACETABULAR COMPONENT AND METASUL LDH ZIMMER GMBH:NO PRODUCT WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIAT
DUROM ACETABULAR COMPONENT AND METASUL LDH LA ZIMMER GMBH:THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
DUROM HIP RESURFACING SYS, FEMORAL COMPONE ZIMMER GMBH:(B) (4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. (B) (4).
DUROM HIP RESURFACING SYSTEM, FEMORAL C ZIMMER GMBH:(B) (4). CONCLUSION: THE INVESTIGATION SHOWS THAT THERE IS NO SIGN OF A MATERIAL OR PRODUCTION FAILU
DWJ - CONVECTIVE WARMER SMITHS MEDICAL ASD, INC.:.
DWJ -- CONVECTIVE WARMER SMITHS MEDICAL ASD, INC.:CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE
DYB / INTRODUCER, CATHETER W.L. GORE & ASSOCIATES:ON (B) (6) 2010, THE PATIENT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A PATENT
DYB INTRODUCER, CATHETER COOK INC.:AN (B) (6) MALE PATIENT UNDERWENT AAA REPAIR ON (B) (6) 2010. THE PHYSICIAN WAS UTILIZING ANOTHER MA
DYB INTRODUCER, CATHETER COOK, INC.:THE PHYSICIANS ARE FINDING, POST OP, THAT THESE DEVICES ARE CAUSING INFECTIONS - IN A STERILE ENVIRO
DYB/ INTRODUCER, CATHETER W.L. GORE & ASSOCIATES:IN 2010, THIS PATIENT WAS TREATED FOR A DESCENDING THORACIC ANEURYSM. WHILE REMOVING THE 24FR GORE I
DYB/INTRODUCER, CATHETER W.L. GORE & ASSOCIATES:A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWOR
DYF / PROSTHESIS, VASCULAR GRAFT, OF LESS THAN 6MM W.L. GORE & ASSOCIATES:ADDITIONAL INFORMATION RECEIVED ON 01/27/10 CHANGED THIS EVENT FROM NON-REPORTABLE TO REPORTABLE. A
DYF/PROSTHESIS, VASCULAR GRAFT, OF LESS THAN 6MM D W.L. GORE & ASSOCIATES:RECEIPT OF NEW INFO ON 02/08/10, DEEMED THIS A REPORTABLE EVENT.
DYNESYS ZIMMER GMBH:IT WAS REPORTED THAT THE SURGEON REMOVED DYNESYS CONSTRUCT FROM L2 TO L1 AND IMPLANTED DEVICES FROM
DYNESYS SPINAL SYSTEM ZIMMER GMBH:NO PRODUCT WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE A
DYNESYS SPINAL SYSTEM WITH HA COATED SC ZIMMER GMBH:(B) (4). CONCLUSION: NO PRODUCT WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS DI
DYONICS SHAVER DYONICS:DURING ARTHROSCOPIC SHOULDER SURGERY, THE SURGEON WAS USING A DYONICS SHAVER. WHEN THE SURGEON RELEA
DYSPLASIA CUP / NXT SMITH & NEPHEW ORTHOPAEDICS LTD.:THE DEVICES INVOLVED WERE NOT RETURNED TO THE MFR FOR ANALYSIS. AN INDEPENDENT RESEARCH FACILITY HAS
DYSPLASIA CUP / NXT SMITH & NEPHEW ORTHOPAEDICS, LTD.:IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO STREP INFECTION.
E SERIES ZOLL MEDICAL CORP:COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B) (6) FEMALE PT, THE ELECTRODES WOULD
E SERIES ZOLL MEDICAL CORPORATION:ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR
E-KIT STRYKER ENDOSCOPY SAN JOSE:ADD'L INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.
E-PRESCRIBING, CPOE, POWERCHART CERNER:A DEFECT WAS DISCOVERED IN THE DEVICE THAT CONVERTS INPATIENT MEDICATIONS TO PRESCRIPTIONS. IT HAS T
ECG ELECTRODE CONMED CORPORATION:IT WAS REPORTED THAT, "I RECEIVED BURN LIKE IRRITATIONS ON MY SKIN FROM THE 3 ELECTRODES ATTACHED FO
ECG LEAD CABLE PHILIPS HEALTHCARE:THE PT WAS ADMITTED WITH ACUTE WHEEZE, ASTHMA, AND CONGENITAL CYANOTIC HEART DISEASE WITH A HISTORY
ECHELON 45 ETHICON ENDO-SURGERY, LLC.:IT WAS REPORTED THAT DURING A RIGHT UPPER LOBECTOMY, THE FIRST WHITE RELOAD FIRING WAS ACROSS THE PU
ECLIPSE BED HILL-ROM COMPANY, INC.:BLACK SMOKE WAS COMING FROM THE PATIENT'S HILL-ROM BED FLEXICAIR ECLIPSE - IF 100870, WHICH INVOLVED
ECT UNKNOWN:AFTER RECEIVING ECT TREATMENT, PT IMMEDIATELY EXHIBITED SEVERE COGNITIVE IMPAIRMENT, DIFFICULTY SPEA
EEG STELLATE SYSTEMS:WHILE IN USE, SMOKE WAS NOTED TO BE COMING FROM THE BACK OF THE EEG MACHINE. OUR BIOMEDICAL ENGINEE
EEG MACHINE CAREFUSION 209, INC.:THE HOSPITAL USES A NIC VUE SYSTEM CONSISTING OF EEG MACHINE WHICH MAY BE USED ANYWHERE IN THE HOSPI
EEG MEASUREMENT MODULE WITH BIS INDEX GE HEALTHCARE FINLAND OY:GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED EVENT IS ONGOING. A SUPPLEMENTAL REPORT WILL BE FILE
EEG SYSTEM CAREFUSION:ON JAN 14, 2010, THE EPILEPSY DEPT REPORTED AN ISSUE WITH VEEG EQUIPMENT IN A ROOM THAT WAS OPENED I
EEG WORKSTATION CAREFUSION 209, INC.:THE HOSPITAL USES A NIC VUE SYSTEM CONSISTING OF EEG MACHINE WHICH MAY BE USED ANYWHERE IN THE HOSPI
ELASTOMERIC BAXER HEALTHCARE CORPORATION:PATIENT WAS DRIVING, DID NOT DISCONNECT INTERMATE UNTIL APPROXIMATELY 15 MINUTES UNTIL AFTER COMPLET
ELASTOMERIC INFUSION DEVICE BAXTER HEALTHCARE CORP:PT ON VANCOMYCIN 1500 MG IV Q12H IN THE HOME IN 2009. THE SAME MONTH, THE PT REPORTED THAT 2 OF HIS
ELBOW IMPLANT BIOMET:RADIAL HEAD INDICATED UNCOUPLED FROM THE IMPLANT STEM. IT WAS ALSO INDICATED THAT THE LOCKING SCREW
ELBOW PROSTHESIS ZIMMER, INC.:EVAL SUMMARY: NO PRODUCT WAS RETURNED FOR EVAL. ALSO, NO X-RAYS AND/OR OPERATIVE NOTES WERE RETURNED
ELECTRIC HI LO TREATMENT TABLE MIDLAND MANUFACTURING:DEVICE WAS EVALUATED BY THIRD PARTY FORENSIC TESTING COMPANY. UNIT WAS FULLY FUNCTIONAL AND DID NOT
ELECTRIC HI-LO TREATMENT TABLE MIDLAND MFG CO. / PATTERSON MEDICAL:CHILD HAD HIS HEAD CAUGHT UNDER TREATMENT TABLE AND WAS STANDING ON THE DOWN MECHANISM, INJURING HIS
ELECTROCAUTERY UNIT TYCO HEALTHCARE GROUP:IMPROPER HANDLING OF ELECTROCAUTERY UNIT DURING SURGERY CAUSING 2 CM BURN AREA ON MID-LATERAL ABDOMI
ELECTRODE OLYMPUS MEDICAL SYSTEM CORPORATION:THE USER FACILITY REPORTED THAT THE PATIENT SUSTAINED THERMAL INJURY IN THE URETHRA AFTER HAVING UND
ELECTRODE ZOLL MEDICAL CORPORATION:ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION, AND THIS COMPLAINT IS STILL UND
ELECTRODE ESU, DISPERSIVE PAD COVIDIEN (VALLEYLAB):UPON REMOVING THE BOVIE PAD, A LESS-THAN DIME SIZE SPOT OF BLOOD WAS NOTED. AFTER WASHING THE BLOOD
ELECTRODE, DEFIBRILLATOR, ADULT ZOLL:THE PATIENT WAS CARDIOVERTED X 3. #1. 120J 155.5 DELIVERED, #2 120J SELECTED 158.4 DELIVERED, 3RD S
ELECTRODE, DEFIBRILLATOR, PEDIATRIC ZOLL MEDICAL CORPORATION:DURING A PATIENT EVENT A ZOLL DEFIBRILLATOR WAS BEING PREPPED FOR STANDBY. STAFF NEEDED A MULTI-FUNC
ELECTRODE, ECG, PREWIRED, NEONATAL/PEDIATRIC PHILIPS:A PUPPYDOG PREWIRED NEONATAL/PEDIATRIC RADIOLUCENT ELECTRODE NOTED TO HAVE BURNED THE PATIENT'S SKIN
ELECTRODE, ESU, HANDSWITCHING PENCIL COVIDIEN (VALLEYLAB):UPON REMOVING THE BOVIE PAD, A LESS-THAN DIME SIZE SPOT OF BLOOD WAS NOTED. AFTER WASHING THE BLOOD
ELECTRODE, ESU, REPLACEABLE TIP, LONG COVIDIEN (VALLEYLAB):UPON REMOVING THE BOVIE PAD, A LESS-THAN DIME SIZE SPOT OF BLOOD WAS NOTED. AFTER WASHING THE BLOOD
ELECTRODES CARDIAC SCIENCE CORP:THE SUPERVISOR COULD NOT RETRIEVE THE ELECTRODES AFTER THE EVENTS (THEY WERE DISCARDED), THEREFORE,
ELECTRODES PHILIPS MEDICAL SYSTEMS:CUSTOMER DESCRIPTION OF ELECTRODES DOES NOT MATCH CONSTRUCTION OF PHILLIPS PRODUCT. LOT NUMBER PROVI
ELECTRODES, DEVICE, ELECTROCONVULSIVE THERAPY SOMATICS LLC:PATIENT UNDERGOING ECT TREATMENT FOR BIPOLAR DISORDER. THE SKIN OF THE POST-AURICULAR, FOREHEAD, AN
ELECTRODES, INFANT HEARING SCREENER NATUS MEDICAL INC:THE NURSES HAVE COMPLAINED MANY TIMES ABOUT THE DIFFICULTY OF USING THE NATUS HEARING SCREENER; ESPE
ELECTROHYDRAULIC LITHOTRIPTOR GYRUS ACMI:PT IN OPERATING ROOM FOR CYSTOSCOPY AND REMOVAL OF BLADDER STONE VIA ELECTROHYDRAULIC LITHOTRIPTOR.
ELECTROSHOCK MECTA NOW OWNED BY GORHAM AND ROBIN NICOL:BILATERAL ELECTROCONVULSIVE THERAPY -ECT- 'TREATMENTS' WERE ADMINISTERED TO ME AS AN INPATIENT FROM
ELECTROSURGICAL ACCESSORY COVIDIEN LP (VALLEY LAB):THE CUSTOMER REPORTED THAT THE PT RECEIVED A BURN ON THE MOUTH DURING A T+A PROCEDURE. THE PT WAS BU
ELECTROSURGICAL ACCESSORY COVIDIEN LP (VALLEYLAB):THE CUSTOMER REPORTED THAT THE CAUTERY PENCIL TIP CAUGHT FIRE AND HAD AN ACTUAL FLAME LIKE A CANDLE.
ELECTROSURGICAL ACCESSORY COVIDIEN LP, (VALLEYLAB):(B) (4). THE INCIDENT WAS DISCOVERED 3 DAYS POST-OPERATIVELY, NO PRODUCT WAS SAVED FOR EVAL. ADD'L Q
ELECTROSURGICAL CUTTING & COAGULATION DE ARTHROCARE CORP.:ON (B) (6) 2009, THE PATIENT UNDERWENT AN ARTHROSCOPY OF THE RIGHT SHOULDER JOINT AND AN ARTHROSCOPI
ELECTROSURGICAL CUTTING & COAGULATION DE ARTHROCARE CORPORATION:ON (B) (6) 2010, THE PATIENT UNDERWENT A KNEE SURGERY OF THE LATERAL MENISCUS USING A SUPER TURBOVAC
ELECTROSURGICAL CUTTING AND COAGULATION ATRICURE, INC.:ADD'L MODEL# EMR2. ADD'L CATALOG# A000452. (B) (4). PURCHASE RECORDS WERE EVALUATED TO DETERMINE THE
ELECTROSURGICAL CUTTING AND COAGULATION VNUS MEDICAL TECHNOLOGIES:ON (B) (6) 2010 AT 11:30 AM, A PHYSICIAN TREATED THE RIGHT GREATER SAPHENOUS VEIN. ULTRASOUND REVEAL
ELECTROSURGICAL CUTTING AND COAGULATION VNUS MEDICAL TECHNOLOGIES, INC.:IT WAS REPORTED THAT A GSV CLOT IS EXTENDING INTO THE CFV. PT RECEIVED CLOT IN RIGHT LEG. PT WAS PRE
ELECTROSURGICAL DEVICE VALLEYLAB:SURGEON WAS USING THE LIGASURE LS1500 AND NOTED THAT THE TRIGGER WAS STICKING MULTIPLE TIMES WHICH D
ELECTROSURGICAL GENERATOR COOPERSURGICAL, INC.:THE PT RETURN PAD USED WAS P/N 6050P, LOT 0808151. THIS LOT IS DUE TO EXPIRE IN AUGUST 2010. THIS LO
ELECTROSURGICAL GENERATOR COVIDIEN LP (VALLEYLAB):THE MEDWATCH STATES: THE PT WAS POSITIONED FOR THE FIRST PROCEDURE, WHICH WAS A CIRCUMCISION. THE PT
ELECTROSURGICAL GENERATOR COVIEIDN LP (VALLEYLAB):THE CUSTOMER REPORTED THAT WHEN A NURSE HANDLED THE FOOT SWITCH, SHE RECEIVED A STRONG ELECTRICAL SH
ELECTROSURGICAL GENERATOR ERBE ELECTROMEDIZIN GMBH:THE ESU WAS RETURNED AND THOROUGHLY INSPECTED/TESTED. THE UNIT WAS FOUND TO BE FUNCTIONING AS INTEND
ELECTROSURGICAL GENERATOR WALLACH SURGICAL DEVICES:THE SUBJECT GENERATOR WAS RETURNED WITH THE INTEGRATION UNIT (P/N 909080). NO ACCESSORIES WERE RETUR
ELECTROSURGICAL GENERATOR / ESU CONMED ELECTROSURGERY:THE PT WAS HAVING A MOLE REMOVED FROM HER LOWER ABDOMEN. THE PT WAS APPREHENSIVE TO UNDERGO THE PROC
ELECTROSURGICAL GENERATOR CAUTERIZE MACHINE VALLEYLAB:WHILE USING THE LAPAROSCOPY INSTRUMENTS FOR A SURGICAL PROCEDURE, A SPARK AND FLAME WAS NOTICED AT T
ELECTROSURGICAL INSTRUMENT INTUITIVE SURGICAL, INC.:RESULTS/CONCLUSIONS: THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT,
ELECTROSURGICAL INSTRUMENT ACCESSORY INTUITIVE SURGICAL, INC.:IT WAS REPORTED THAT DURING A DA VINCI S GYNECOLOGICAL PROCEDURE, AN ARC WAS OBSERVED COMING FROM TH
ELECTROSURGICAL PAD 3M HEALTH CARE:CUSTOMER REPORTED TO FDA ((B) (4)) THAT A PT RECEIVED A DEEP 3RD DEGREE BURN AT THE SITE OF THE ELEC
ELECTROSURGICAL PENCIL CONMED:OVER THE PAST SEVERAL DAYS WE HAVE HAD IN OUR SURGERY DEPARTMENT 3 INSTANCES WHERE CONMED BOVIE PENC
ELECTROSURGICAL PENCIL CONMED CORPORATION:ARGON BEAM COAGULATION PENCIL WAS OUT OF HOLSTER ON THE STERILE FIELD ON DRAPED ABDOMEN AS PLACED BY
ELECTROSURGICAL PENCIL VALLEY LAB:PATIENT WAS IN THE OR HAVING AN EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, LEFT SALPINGO-OOPHRECTOM
ELECTROSURGICAL PENCIL/BOVIE CONMED ELECTROSURGERY:THE INSTRUCTIONS FOR USE FOR THE HYFRECATOR HANDPIECE (7-800-5) STATE: CONTRAINDICATIONS: THESE DEVI
ELECTROSURGICAL UNIT CELON AG MEDICAL INSTRUMENTS:THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC COLONOSCOPY WITH POLYPECTOMY, THE USERS HAD OBS
ELECTROSURGICAL UNIT CONMED ELECTROSURGERY:DEVICE COMES FROM MANUFACTURER WITH SET UP OPTION SET TO "LAST SETTING." IN THIS MODE WHEN DEVICE I
ELECTROSURGICAL UNIT COVIDIEN (VALLEY LAB):RESEARCHED POTENTIAL REASONS FOR HAND CABLE TO OVERHEAT. SPOKE THE O/R STAFF AND THEY BOTH SPECULATE
ELECTROSURGICAL UNIT COVIDIEN- VALLEY LAB PFIZER:SURGICAL FIRE OCCURRED DURING EXCISION OF CYST FROM LEFT CHEEK.
ELECTROSURGICAL UNIT AND ACCESSORIES SOLTA:ON (B) (6) 2009, SOLTA WAS NOTIFIED OF AN EVENT WHERE A PATIENT HAD BEEN TREATED WITH A THERMAGE PRO
ELECTROSURGICAL UNIT AND ACCESSORIES SOLTA MEDICAL:ON (B) (6) 2009, SOLTA WAS NOTIFIED OF AN EVENT WHERE A PHYSICIAN TREATED HERSELF WITH A THERMAGE TG
ELECTROSURGICAL UNIT AND ACCESSORIES THERMAGE:ON (B) (6) 2009, SOLTA WAS NOTIFIED OF AN EVENT WHERE AN OPERATOR HAD BEEN INJURED WHILE DELIVERING
ELECTROSURGICAL UNIT/ESU CONMED ELECTROSURGERY:PROCEDURE: TONSILLECTOMY. THE REMOVAL WENT FINE, BUT THE SURGERY STAFF NOTICED THE PT'S MOUTH WAS BU
ELECTROSURGICAL UNIT/GENERATOR (ESU) CONMED ELECTROSURGERY:DURING A GASTRIC BYPASS, THE PT'S SPLEEN STARTED TO BLEED. THE SYSTEM 7500 DID NOT WORK TO THE PHYSI
ELECTROSURGICAL, CUTTING & COAGULATING DEPUY MITEK:MITEK IS AT THIS POINT IN TIME IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOR
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORI ARTHREX, INC.:IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR CASE, THE SURGEON NOTED A HOLE ON THE SIDE OF THE
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORI BOSTON SCIENTIFIC - MARLBOROUGH:NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORI BOSTON SCIENTIFIC - SPENCER:THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THER
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORI ETHICON ENDO-SURGERY, LLC.:INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT.
ELECTROSURGICAL, CUTTING AND COAGULATING DEPUY MITEK:MITEK IS AT THIS POINT IN TIME IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOR
ELECTROTHERMAL GENERATOR / GEI BROOKS MANUFACTURING SITE:THIS DEVICE HAS NOT BEEN RECEIVED FOR EVAL, THEREFORE, INVESTIGATION RESULTS ARE INCONCLUSIVE. IF TH
ELEVATE JOERNS HEALTHCARE (DISTRUBUTOR):DISPLACED LEFT HUMERAL NECK FRACTURE. (B) (6) WAS SUSPENDED IN THE HOYER LIFT, THE LIFT BEGAN TO WOR
EMBOLIC COIL MICRUS ENDOVASCULAR CORP:SINCE THE PRODUCTS WERE IMPLANTED, IT COULD NOT BE RETURNED FOR EVAL. WITHOUT THE RETURN OF THE DEVI
EMBOLIC PROTECTION DEVICE ABBOTT VASCULAR:PATIENT HAD IN-STENT RESTENOSIS OF A TORTUOUS, CALCIFIED, LEFT INTERNAL CAROTID ARTERY LESION; PLAN
EMBOLIC PROTECTION DEVICE BOSTON SCIENTIFIC CORPORATION:THE STRAIGHT SHEATH INCLUDED IN THE SYSTEM BROKE IN TWO PIECES. THIS OCCURRED OUTSIDE THE PATIENT'S
EMBOLIC PROTECTION DEVICE CORDIS CORPORATION:THE PT WAS PRE-MEDICATED WITH ATROPINE 0.5 MG PRIOR TO PRE-DILATATION. FOLLOWING STENT DEPLOYMENT TH
EMBOLIC PROTECTION DEVICE (NTE) CORDIS CORPORATION:IT WAS INITIALLY REPORTED VIA THE REGISTRY THAT A PT EXPERIENCED AN ISCHEMIC STROKE DURING POST-DILA
EMBOLIZATION COIL MICROVENTION, INC.:SAMPLE ANALYSIS: THE DEVICE WAS RETURNED WITH THE COIL DETACHED FROM THE DELIVERY PUSHER. THE IMPLAN
EMR SYSTEM CERNER CORP.:WE HAVE A CERNER EMR SYSTEM THAT IS CONNECTED TO A PHILIPS PATIENT MONITORING SYSTEM TO CHART VITAL
ENDCAP WARSAW ORTHOPAEDIC INC.:(B) (4): NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR
ENDO CATCH GOLD 10MM UNITED STATES SURGICAL/COVIDIEN:DURING LAPAROSCOPIC APPENDIX REMOVAL, WHILE RETRIEVING THE APPENDIX, THE POUCH ON 3 DIFFERENT ENDO C
ENDO GIA HANDLE TYCO:ENDO GIA HANDLE AND RELOAD GIVEN TO SURGEON AT THE FIELD-REPORTED "NOT WORKING" AND REQUESTED ANOTHE
ENDO GIA UNIVERSAL UNITED STATES SURGICAL, AUTO SUTURE:DURING A THORACOSCOPY, WEDGE RESECTION OF THE RIGHT UPPER LOBE WAS DONE. THERE WAS SOME STAPLING MIS
ENDO LINEAR CUTTERS ETHICON ENDO SURGERY, INC (CINCINNATI):(B) (4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
ENDOBUTTON CL ULTRA, 20MM / GAT MANSFIELD MANUFACTURING SITE:FOR SOME UNK REASON NOT REPORTED BY CUSTOMER THE PT RETURNED TO THE O.R. FOR CULTURES AND WASHOUT OF
ENDOCLIP BOSTON SCIENTIFIC CORP. HEAD QUARTERS:PT NEEDED CLIP PLACED TO BIOPSY SITE AFTER CAUTERY FAILED TO STOP BLEEDING. FIRST TWO CLIPS DID NOT
ENDOCLIP 2 COVIDIEN:CLIP APPLIER MALFUNCTION.
ENDOFEMORAL AIMER, 5MM OFFSET / NBH MANSFIELD:DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. (B) (4). (B) (4).
ENDOGIA COVIDIEN:ENDO GIA UNIVERSAL ROTICULATOR STAPLER. USED 2 LOADS AND ONE OF THE STAPLE MISFIRED, IT STAPLED THE
ENDOMETRIAL ABLATION DEVICE HOLOGIC, INC.:THE MACHINE WAS SET UP AND THE NUMBERS WERE PUT INTO THE CORRECT SPOTS FOR CAVITY LENGTH AND WIDTH.
ENDOSCOPE AND/OR ACCESSORIES, DILATOR, ESOPHAGEAL BOSTON SCIENTIFIC - CORK:IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B) (6) 2010 THAT A CRE WIREGUIDED BALLOON DILAT
ENDOSCOPE DISINFECTOR MEDIVATORS REPROCESSING SYSTEMS, DIV. OF MINNTECH:PER DR (B) (6): THE COLONOSCOPY WAS PERFORMED IN (B) (6) 2009, WITH NO COMPLICATIONS OR PATIENT INJU
ENDOSCOPIC CURVED INTRALUMINAL STAPLER ETHICON ENDO-SURGERY, INC.:SIZER INSERTED INTO THE COLON THROUGH THE RECTUM, SIZER CONNECTED TO THE ANVIL, SIZER CLOSED AND SAF
ENDOSCOPIC CURVED INTRALUMINAL STAPLER ETHICON ENDO-SURGERY, LLC.:INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
ENDOSCOPIC CYTOLOGY BRUSH BOSTON SCIENTIFIC - SPENCER:THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT
ENDOSCOPIC GRASPER SGL-ACT5MM AESCULAP:THE PATIENT IS A (B) (6) FEMALE WHO HAD A LAPAROSCOPIC CHOLECYSTECTOMY AND INTRAOPERATIVE CHOLANGIOG
ENDOSCOPIC INSTRUMENT CONTROL SYSTEM INTUITIVE SURGICAL, INC.:AN INVESTIGATION CONDUCTED BY AN ISI CLINICAL SALES REP FOUND THAT THE SURGEON WAS UNABLE TO DETERMI
ENDOSCOPIC INSTRUMENT CONTROL SYSTEM INTUITIVE SURGICAL,INC.:IT WAS REPORTED, THAT WHILE MOBILIZING THE LEFT INTERNAL MAMMARY ARTERY DURING A DA VINCI S CABG PRO
ENDOSCOPIC MONOPOLAR LOOP LINA MEDICAL APS:DURING LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY, A LINA LOOP WAS PLACED ACROSS UTERUS AND CERVIX. THE
ENDOSCOPIC VESSEL HARVESTING KIT/SYSTEM MAQUET:CAUTERY WAND ATTACHED TO THE SCOPE, IT IS USUALLY ACTIVATED BY A SWITCH. THE WAND WILL CAUTERIZE VEI
ENDOSCOPIC VESSEL HARVESTING SYSTEM MAQUET:PA WAS USING THE DEVICE TO TAKE LEG VEIN FOR USE IN CARDIAC BYPASS SURGERY. AFTER APPROXIMATELY 35
ENDOSCOPIC VESSEL HARVESTING SYSTEM MAQUET CARDIOVASCULAR LLC:DURING VEIN HARVESTING AS PART OF TRIPLE VESSEL CORONARY ARTERY BYPASS, THE CLEAR END OF THE EVH DEV
ENDOSCOPIC VESSEL HARVESTING SYSTEM SORIN GROUP USA, INC.:BIPOLAR DEVICE BEING USED ON PATIENT RIGHT LOWER LEG. PROVIDER WAS USING BIPOLAR TIP AND A 2MM PLAST
ENDOSCOPIC VIDEO SYSTEM, VIDEO MONITOR STRYKER ENDOSCOPY:VIDEO TOWER SCREEN WENT BLANK AND UNABLE TO GET PICTURE WHEN MD STARTED USING SCOPE, VIDEO TOWER SWI
ENDOSCOPIC, LAPAROSCOPE, GYNECOLOGIC, AND ACCESSOR KARL STORZ ENDOSCOPY-AMERICA, INC.:UNABLE TO PROPERLY CLEAN MORCELLATOR. AFTER MULTIPLE WASHINGS, BLOOD TINGED FLUID CONTINUES TO FLOW
ENDOSSEOUS DENTAL IMPLANT DENTIUM:ACCORDING TO OUR INVESTIGATION, THERE WAS NO DISCREPANCY ON OUR PRODUCT. CONCLUSION: BASED ON OUR IN
ENDOSSEOUS DENTAL IMPLANT DENTIUM USA:CONCLUSION: BASED ON INSPECTION AND TEST RESULTS, THE RETURNED PRODUCT HAS BEEN FOUND TO BE WITHIN S
ENDOSUTURE SYSTEM ETHICON ENDO-SURGERY - JOHNSON AND JOHNSON, LLC:A WHITE (B) (6) FEMALE ADMITTED FOR A LAPAROSCOPIC NISSAN FUNDOPLICATION TO REPAIR A PARAESOPHAGEAL
ENDOTRACHEAL TUBE COVIDIEN / FORMERLY TYCO HEALTHCARE:THE CUSTOMER REPORTED THAT THE TUBE WAS PLACED IN THE PATIENT ON (B) (6) 2010 AND THE CUFF FAILED LA
ENDOTRACHEAL TUBE COVIDIEN, FORMERLY TYCO:COVIDIEN RECEIVED A REPORT THAT A CUFF "BLEW" ON THE ENDOTRACHEAL TUBE AFTER IT WAS IN USE FOR 24 HO
ENDOTRACHEAL TUBE COVIDIEN, FORMERLY TYCO HEALTHCARE:THE CALLER REPORTED SOMETIME DURING THE PAST TWO MONTHS, THEY EXPERIENCED DIFFICULTY WITH SECRETIONS
ENDOTRACHEAL TUBE COVIDIEN/ FORMERLY TYCO HEALTHCARE:THE CUSTOMER REPORTED THAT DURING USE THEY CONFIRMED ASYMMETRICAL INFLATION OF THE CUFF. A NON-ROUTI
ENDOTRACHEAL TUBE COVIDIEN/FORMERLY TYCO HEALTHCARE:THE CALLER REPORTED THAT SOMETIME DURING THE PAST TWO MONTHS, THEY EXPERIENCED DIFFICULTY WITH SECRE
ENDOTRACHEAL TUBE HOLDER NEOTECH PRODUCTS, INC.:A BABY DETERMINED TO BE TERMINAL WAS TO HAVE THE LIFE SUPPORT SYSTEMS DISCONTINUED AFTER THE MORNING
ENDOTRACHEAL TUBE HOLDER SMITHS MEDICAL ASD INC.:ADMITTED TO HOSPITAL ON (B) (6) 2009 FOR UTI, SEPSIS, LEUKOCYTOSIS, RLL INFILTRATE, RHABDOMYOLYSIS,
ENDOTRACHEAL TUBE INTRODUCER SUN MED:ANESTHESIA INSERTED ET TUBE AND ENDOTRACHEAL TUBE INTRODUCER "STYLET" IN OR. APPROXIMATELY 3 1/2 HOU
ENDOURETHRAL PROSTHESIS AMERICAN MEDICAL SYSTEMS, INC.:PATIENT WAS IMPLANTED WITH UROLUME STENT ON (B) (6) 1997. ON (B) (6) 2008, PATIENT REPORTED HIS UROL
ENDOVASCULAR GRAFT COOK, INC.:A 38 TAPERING TO 34 COOK GRAFT WAS INTRODUCED THROUGH THE COMMON FEMORAL VESSEL AND BROUGHT TO THE L
ENDOVASCULAR GRAFT ENDOLOGIX:AFTER DEPLOYING THE BIFURCATED GRAFT, THE POLYTETRAFLUOROETHYLENE (PTFE) LIMB COVER FROM THE LEFT SI
ENDOVASCULAR SDS/STENTS (FGE) CORDIS CORPORATION:IT WAS REPORTED THAT THE 19MM GENESIS STENT WAS IMPLANTED IN THE OSTIUM OF THE LEFT PULMONARY ARTERY
ENDOVASCULAR SDS/STENTS (FGE) CORDIS EUROPA, N.V.:THE PRODUCT IS NOT AVAILABLE FOR EVAL AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS
ENDOVASCULAR WIRES & METALS (DQX) CORDIS CORPORATION:DURING THE PROCEDURE, THE PHYSICIAN USED A BALLOON CATHETER TO TREAT THE LEFT SUPERFICIAL FEMORAL AR
ENSITE CLASSIC SYSTEM ST. JUDE MEDICAL:WE ARE IN PROCESS OF INVESTIGATING THIS EVENT. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION
ENTREE II 5-12 MM VALVE/REDUCER CONMED CORPORATION:MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO FROM FACILITY WITHOUT COOPERATION. AT THIS TIM
EPIDURAL FILTER SMITHS MEDICAL:ACUTE PAIN SERVICE (APS) CALLED TO SEE PATIENT FOR INCREASED PAIN, SCORE 8-9 OUT OF 10. HER PAIN HAD
EPIDURAL PUMP HOSPIRA GLOBAL MEDICAL AFFAIRS:IT WAS REPORTED THAT PATIENT WAS FOUND FACE DOWN IN BED. PATIENT WAS UNRESPONSIVE SO A CODE WAS INIT
ESOPHYX DEVICE ENDOGASTRIC SOLUTIONS:DURING THE PROCEDURE TOWARDS THE END WHILE EVALUATION, THE AREA OF THE VALVE DIFFICULTY WAS ENCOUNTE
ESSENZA SCANNER SIEMENS MEDICAL:PT WAS SCANNED FOR A RIGHT SHOULDER MRI IN THE SIEMENS ESSENZA SCANNER. OUR NORMAL SHOULDER SEQUENCE
ESSURE CONCEPTUS:ESSURE BIRTH CONTROL DEVICES WERE IMPLANTED IN (B) (6) 2008. IMMEDIATELY AFTER AND UNTIL THE DEVICES
ESSURE CONCEPTUS INC.:ESSURE IMPLANT PERFORATION IN UTERUS ADHERING TO APPENDIX. CORKSCREWING ORGANS TOGETHER REQUIRING AP
ESSURE CONCEPTUS INCORPORATED:THE ESSURE MICRO-INSERT DID NOT DEPLOY PROPERLY IN THE RIGHT FALLOPIAN TUBE, COILING UP IN THE UTERU
ESU CONMED:WHILE DOING A LAP CHOLECYSTECTOMY, A PROBLEM WAS NOTICED WITH THE ELECTRICAL SURGICAL UNIT -ESU-. IT
ESU COVIDIEN (VALLEYLAB):UPON REMOVING THE BOVIE PAD, A LESS-THAN DIME SIZE SPOT OF BLOOD WAS NOTED. AFTER WASHING THE BLOOD
ESU VALLEYLAB / COVIDIEN:PHYSICIAN ATTEMPTED TO USE COAG FUNCTION ON FORCEFX CAUTERY, DEVICE DID NOT WORK. CUT FUNCTION WORKE
ESU LOW POWER CONMED CORP; BIRTCHER CORP:DURING ELECTRIC CAUTERY , HYFRECATOR CAUGHT ON FIRE, NO DAMAGE DONE TO ROOM ONLY HYFRECATOR. PATIE
ESU RETURN PAD CORD AESCULAP:WHILE DOING A LAP CHOLECYSTECTOMY, A PROBLEM WAS NOTICED WITH THE ELECTRICAL SURGICAL UNIT -ESU-. IT
ESU UNIT VALLEYLAB:DURING INITIAL INCISION USING AN ELECTROSURGICAL UNIT SET AT 20 CUT AND 20 COAGULATION (CUTTING THRO
ESW PROSTHESIS, ESOPHAGEAL COOK IRELAND LTD:THE ESOPHAGEAL STENT INVOLVED IN THIS REPORT WAS NOT RETURNED FOR EVAL; THEREFORE, THE REPORTED OCCU
ETERNITY X-70 ADVANCED VISION SCIENCE, INC:AFTER THE LENS WAS IMPLANTED, THE SURGEON NOTICED THE OPTIC WAS CHIPPED. HE ENLARGED THE INCISION TO
ETERNITY X-70 ADVANCED VISION SCIENCE, INC.:AFTER IMPLANTING THE LENS, HAPTIC WAS FOUND BROKEN. AS THE LENS WAS BEING REMOVED, THE CORNEAL ENDOT
EVLT KIT ANGIODYNAMICS UK LTD:CUSTOMER IS NOT RETURNING DEVICE, SO WE ARE UNABLE TO CARRY OUT A PHYSICAL EXAMINATION OF THE DEVICE
EXAMINER LASER - WAVEFRONT UNK:POST LASIK DRY EYE - LOSS OF TEAR PRODUCTION DUE TO CORNEA NERVE DAMAGE. THIS IS A SEVERE DRY EYE CO
EXCIMER LASER DEVICE NIDEK:I HAD A LASIK SURGERY IN 2005. I HAD -5.75 IN LEFT EYE. AFTER THAT, FOR 2 YEARS, I HAD A GOOD VISION
EXCIMER LASER SYSTEM ALCON - ORLANDO TECHNOLOGY CENTER:INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECE
EXPANDER, BREAST TISSUE MENTOR:PATIENT RECEIVED BREAST A TISSUE EXPANDER AND RETURNED TO SURGERY TWO MONTHS LATER TO HAVE THE TISSU
EXTENDER MEDTRONIC SOFAMOR DANEK:(B) (4). A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL
EXTERMITY REPLACEMENT DEPUY ORTHOPAEDICS, INC.:SUSPECTED LOOSE TIBIA FOUND NOTHING, CHANGED TO A LARGER TALUS AND TIBIA COMPONENTS. REVISED FOR PAI
EXTERNAL PULSE GENERATOR MEDTRONIC MILACA INC.:THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITION
EXTERNAL PULSE GENERATOR MEDTRONIC, INC.:THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS
EXTREMITY REPLACEMENT DEPUY ORTHOPAEDICS, INC.:THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAMINATION. THE PRODUCT CODE
EYEGLASS FRAME HAZARD BEST WAY MFG & TRADING CO LTD:THIS IS TO BRING TO THE ATTENTION OF THE (B) (4) A SAFETY HAZARD TO THE EYES INHERENT IN THE STYLING
EZ TRODE METTLER ELECTRONICS CORP.:ON 02/16/2010, A COPY OF MEDWATCH REPORT (PATIENT (B) (6)) WAS RECEIVED IN (B) (4) MAIL. PER THIS RE
EZ-IO POWER DRIVER VIDACARE CORP:VIDACARE G3 EZ-IO POWER DRIVER ACTIVATED WHILE IN THE PROTECTIVE CASE WITH THE TRIGGER GUARD IN PLAC
FACET SCREW WARSAW ORTHOPEDIC INC.:IT WAS REPORTED THAT THE PT UNDERWENT AN "AXIAL LUMBAR INTERBODY FUSION" FROM L5-S1 USING PEDICLE SC
FACIAL FILLER AVENTIS PHARMA GRUPPO LEPETIT S.R.L.:FINAL REPORT, NO NEW INFO. (B) (4). THE REVIEW OF THE DHR (DEVICE HISTORY RECORDS) AND OF THE ANALYT
FACIAL FILLER SANOFIAVENTIS U.S LLC:ON 21-JAN-10, DEVICE QC PERFORMED. TO'B. ON 16-FEB-10, DEVICE QC PERFORMED. TO'B.
FACIAL FILLER SANOFIAVENTIS U.S. LLC:DEVICE QC CHECK PERFORMED.
FACIAL FILLER SANOFIAVENTIS U.S., LLC.:INITIAL INFO RECEIVED FROM A PHYSICIAN AND A SALES REP ON 12/18/2009: THIS NON-SERIOUS CASE WAS RECE
FACIAL FILLER SANOFIAVENTIS US LLC:INITIAL REPORT: THIS SPONTANEOUS CASE WAS REPORTED IN 2009 BY A CONSUMER VIA AN EMAIL TO A SALES REP
FACIAL RECONSTRUCTION POREX SURGICAL:THE DOCTOR STATED THAT THE PATIENT RECEIVED A MEDPOR MANDIBLE IMPLANT. THE DOCTOR STATED THAT HE PLA
FACIAL RECONSTRUCTION POREX SURGICAL, INC.:ADD'L LOT NUMBER: MCI-414-09-E021J95H. FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT N
FAD STENT, URETERAL COOK IRELAND LTD:AN ENDOSCOPY OPERATION (GENERAL CYSTOSCOPY) WAS CARRIED OUT ON THE (B) (6) 2010. IT WAS NO POSSIBLE
FAD STENT, URETERAL COOK UROLOGICAL INC:THE METAL BAND CAME OFF THE POSITIONER IN THE PT'S KIDNEY DURING PLACEMENT. DOING FINE.
FAD STENT, URETERAL COOK UROLOGICAL, INC.:DURING A CYSTOSCOPY/URETEROSCOPY FOR STENT REMOVAL, THE STENT CLEAVED AT THE MIDPOINT WITH A PORTION
FALLOPIAN TUBE CONCEPTUS:GYNECOLOGIST DR (B) (6) RECOMMENDED ESSURE FOR PERMANENT BIRTH CONTROL. I WAS ADVISED TO HAVE THE DE
FASCIAL CLOSURE DEVICE KARL STORZ ENDOSCOPY - AMERICA, INC.:INTACT NON-DISPOSABLE ENDOCLOSE DEVICE GIVEN TO PHYSICIAN. WHEN TRYING TO USE IT, IT WAS IDENTIFIED
FAST CATH INTRODUCER ST. JUDE MEDICAL:ONE 11F, 12CM, FAST-CATH HEMOSTASIS SHEATH WAS VISUALLY INSPECTED. THE SHEATH TUBING HAD BEEN COMPLE
FAST-CATH 5F, 12 CM ST. JUDE MEDICAL:NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER W
FAST-CATH 8F, 12CM ST. JUDE MEDICAL:IT WAS REPORTED DURING AN ELECTROPHYSIOLOGY ABLATION PROCEDURE, A 5F FAST CATH HEMOSTASIS INTRODUCER
FAST-CATH TRANSSEPTAL ST. JUDE MEDICAL, AF DIVISION:THE DEVICE WAS NOT RETURNED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MA
FASTENER, FIXATION BIOMET SPORTS MEDICINE:CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF D
FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE ARTHREX, INC.:FOLLOW UP COMMUNICATION WITH THE EVENT REPORTER PROVIDED ADDITIONAL INFORMATION THAT ONCE TIBIAL GRA
FCG, SET, BIOPSY NEEDLE AND NEEDLE, GASTRO-UROLOGY COOK ENDOSCOPY:EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT OF NEE
FECAL MANAGEMENT SYSTEM CONVATEC:(B) (4). (B) (4).
FECAL MANAGEMENT SYSTEM CONVATEC:REPORTED BY THE COMPLAINANT AS FOLLOWS... A FEMALE PATIENT WITH A LONG HISTORY OF MS DIAGNOSIS WITH
FEMORAL / JWH SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION:IT HAS BEEN REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN.
FEMORAL / LXH SMITH & NEPHEW, INC.:IT HAS BEEN REPORTED THAT A REVISION SURGERY WAS PERFORMED. NO ADDITIONAL INFORMATION HAS BEEN PROVI
FEMORAL COMPONENT / JDH SMITH & NEPHEW AARAU SWITZERLAND MFG SITE:IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO ASEPTIC LOOSENING.
FEMORAL COMPONENT / JDH SMITH & NEPHEW, INC.:IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED, DUE TO ASEPTIC LOOSENING OF THE STEM.
FEMORAL COMPONENT / JDH SMITH & NEPHEW, INC. BROOKS MANUFACTURING SITE:IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO A FRACTURE OF THE DEVICE.
FEMORAL COMPONENT / JDH SMITH & NEPHEW, INC. BROOKS MFG SITE:IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED FOR REASONS UNK.
FEMORAL COMPONENT / JDH SMITH & NEPHEW, INC., BROOKS MANUFACTURING SITE:IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO A FRACTURE OF THE DEVICE. THE PT DIED FRO
FEMORAL COMPONENT / JDH SMITH & NEPHEW, INC., BROOKS MFG SITE:IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A FRACTURE OF THE DEVICE.
FEMORAL COMPONENT IMPACTOR (INSTRUMENT) SMITH & NEPHEW-US ORTHOPEDIC CUSTOMER SERVICE:THIS PT WENT BACK TO THE OR (B) (6) 2009 FOR RETRIEVAL OF A RETAINED SCREW FRAGMENT S/P RIGHT TOTAL
FEMORAL COMPONENT OF THA OMNI LIFE SCIENCE, INC:MECHANICAL TESTS WERE PERFORMED ON SIMILAR DEVICES.
FEMORAL COMPONENT OF THA OMNI LIFE SCIENCE, INC.:MECHANICAL TESTS WERE PERFORMED ON SIMILAR DEVICES.
FEMORAL COMPONENT/ JDH SMITH & NEPHEW, INC. BROOKS MANUFACTURING SITE:IT WAS REPORTED THAT REVISION SURGERY WAS REPORTED DUE TO DISLOCATION.
FEMORAL HEAD / JDH SMITH & NEPHEW, INC., BROOKS:IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN AND ARTHRITIC CHANGES IN HIP.
FEMORAL HEAD / LPF SMITH & NEPHEW, INC., BROOKS MANUFACTURING SITE:IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO A FRACTURE OF THE DEVICE.
FEMORAL HEAD/JDH SMITH & NEPHEW, INC., BROOKS MANUFACTURING SITE:IT WAS REPORTED THAT REVISION WAS PERFORMED DUE TO DISLOCATION.
FEMORAL NAIL STRYKER TRAUMA GMBH:THE PATIENT WAS ADMITTED 3 MONTHS AGO WITH RIGHT SUBTROCHANTER FRACTURE. PATIENT WAS OPERATED ON 3 D
FEMORAL PLATE ZIMMER:PT HAD INTERNAL FIXATION OF FRACTURED LEFT FEMUR ON (B) (6).2009. NO PROBLEMS REPORTED FOLLOWING THE
FEMORAL RESURFACING COMPONENT WRIGHT MEDICAL TECHNOLOGY:THREE YEARS AGO PATIENT HAD A RESURFACING RIGHT TOTAL HIP ARTHROPLASTY. SHE DID WELL FOR A FEW YEAR
FEMORAL STEM / JDH BROOKS:IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO A FRACTURE OF THE DEVICE.
FEMORAL STEM / JDH SMITH & NEPHEW INC:IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO ASEPTIC LOOSENING.
FEMORAL/JWH SMITH & NEPHEW, INC., ORTHOPAEDIC DIVISION:IT HAS BEEN REPORTED THAT A REVISION SURGERY WAS PERFORMED.
FEMORAL/JWH SMITH & NEPHEW, INC./ORTHOPAEDIC DIV:NA
FES CYCLE ERGOMETER RESTORATIVE THERAPIES INC.:PT HAS C1/C2 (B) (6) A SPINAL CORD INJURY. PT EXPERIENCED WRIST FRACTURE PROBABLY WHILE "ONE ARM" FE
FETAL MONITOR PHILIPS HEALTHCARE, INC.:A PT PRESENTING TO LABOR AND DELIVERY IN LABOR. AT 41 WEEK GESTATION AND HISTORY OF PRIOR PLANNED C-
FFL DISLODGER, STONE, BASKET, URETERAL, METAL COOK UROLOGICAL INC:ONE USED STONE EXTRACTOR COILED INSIDE A SURGICAL BOWL WAS RECEIVED. THE ENTIRE BASKET HAS BECOME SE
FFL, DISLODGER, STONE, BASKET, URETHERAL, METAL COOK ENDOSCOPY:EVALUATION: OUR LAB EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT OF BASKET WIR
FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL COOK ENDOSCOPY:EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT OF BAS
FGE CATHETER, BILIARY, DIAGNOSTIC BOSTON SCIENTIFIC:THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS O
FGE CATHETER, BILIARY, DIAGNOSTIC COOK ENDOSCOPY:EVALUATION: WE COULD NOT CONFIRM THE REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED
FGE CATHETER, BILIARY, DIAGNOSTIC COOK IRELAND LTD:THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION; THEREFORE THE CUSTOMER COMPLA
FGE, CATHETER, BILIARY, DIAGNOSTIC COOK ENDOSCOPY:IN 2009, THE PHYSICIAN PLACED A COOK ENDOSCOPY ZILVER EXPANDABLE METAL BILIARY STENT FOR TREATMENT O
FGE, CATHETER, BILIARY, DIAGNOSTIC COOK, INC.:ON (B) (6) 2010, THE PHYSICIAN WAS PERFORMING A RENAL INTERVENTION. THERE WAS A PRIOR STENT PLACED I
FIBER AMERICAN MEDICAL SYSTEMS:NO INJURIES WERE REPORTED. THE FIBER WAS RETURNED FOR FAILURE ANALYSIS. THE FAILURE ANALYSIS CONSIST
FIBER OMNIGUIDE:THE LASER SYSTEM WAS EVALUATED AFTER MALFUNCTION AND FOUND TO BE WORKING PROPERLY. PRIOR TO THE STAR
FIE, FOZ JMS SINGAPORE PTE. LTD:FACILITY REPORTED "WHEN REMOVING FISTULA NEEDLE WING SAFETY DEVICE, EMPLOYEE WAS PULLING TO LOCK NEE
FILLER, BONE VOID, OSTEOINDUCTIVE ETEX CORPORATION:PT UNDERWENT SURGERY FOR POSTEROLATERAL FUSION OF THE LUMBAR SPINE IN 2009. SUBSEQUENT TO THE SURGER
FILTER, INTRAVASCULAR, CARDIOVASCULAR BOSTON SCIENTIFIC:THE GREENFIELD VENA CAVA FILTER FAILED TO DEPLOY PROPERLY IN THE JUGULAR. ONLY ONE PRONG DEPLOYED.
FILTER, INTRAVASCULAR, CARDIOVASCULAR BOSTON SCIENTIFIC - CORK:(B) (6). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR
FINGER PYROLYTIC CARBON PROSTHESIS ASCENSION ORTHOPEDICS, INC.:IT WAS REPORTED THAT THE PT WAS EXPERIENCING JOINT PAIN AND SOME SUBLUXATION WITH HER IMPLANT. IT WA
FINGER SEMI-CONSTRAINED PROSTHESIS TRIAL ASCENSION ORTHOPEDICS, INC.:A REVIEW OF THE DESIGN WAS COMPLETED. IT WAS DETERMINED THAT THE CURRENT VERSION OF TRIALS WERE SLIG
FIXATION DEVICE COVIDIEN LP:INSTRUMENT DID NOT FIRE. OPENED A SECOND ONE AND SAME THING OCCURRED. A THIRD ONE WAS OPENED, WHICH
FIXATION DEVICE COVIDIEN UNITED STATES SURGICAL CORPORATION:SURGEON NOTICED DURING A LAPAROSCOPIC CASE WHILE TACKING MESH FOR VENTRAL HERNIA REPAIR THAT SHARP P
FIXATION DEVICE DEPUY SPINE, INC.:IN 2006, L4-S1 SPINAL INSTRUMENTATION WAS DONE WITH MOSS MIAMI SI HARDWARE. SOMETIME AFTER THE SURGE
FIXATION DRILL BIT MEDARTIS, INC.:PT WAS HAVING AN OPEN REDUCTION INTERNAL FIXATION OF FRACTURED RIGHT THIRD METACARPAL FOLLOWED BY MA
FIXATION, SCREW BIOMET SPORTS MEDICINE:THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. NUMEROUS ATTEMPTS HAVE BEEN MADE
FLAT MESH SHEET -HERNIA SURGERY- UNDETERMINED:PROBLEM: PROBABLE NON AUTHENTIC BARD FLAT MESH SHEET, CODE (B) (4), LOT 48HVS036 (B) (4) (B) (4), HA
FLEXIBLE URETEROSCOPE GYRUS ACMI, INC.:THE PATIENT WAS UNDERGOING A CYSTOSCOPY, LEFT URETEROSCOPY AND LEFT URETERAL STENT EXCHANGE WHEN THE
FLIPPER DETACHABLE EMBOLIZATION COIL COOK:PATIENT HAD A HISTORY OF PATENT DUCTUS ARTERIOSUS AND WAS UNDERGOING A DEVICE CLOSURE. TWO COILS WER
FLOSEAL 5ML SYRINGE BAXTER:PT HAD TO BE ADMITTED ONE WEEK AFTER A LAPAROSCOPIC HYSTERECTOMY, DUE TO ABDOMINAL/PELVIC PAIN, FEVE
FLOW DIRECTED MICRO CATHETER EV3 NEUROVASCULAR:TREATMENT OF A DURAL FISTULA WITH ONYX. IT WAS REPORTED DURING ONYX INJECTION, THE CATHETER BECAME B
FLOWMETER OR SPIROMETER DRAEGER MEDICAL, INC:WE HAD A BROKEN FLOWMETER ON A DRAEGER ANESTHESIA MACHINE. THIS RESULTED IN A HUGE LEAK IN THE ANEST
FLUID MANAGEMENT DEVICE WOLF:DURING ROUTINE HYSTEROSCOPY - IT WAS NOTED AND MD AWARE OF A FLUID DEFICIT. (FLUID MANAGEMENT SYSTEM
FLUID, INTRAOCULAR ALCON - FORT WORTH / ALCON LABORATORIES, INC.:THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIF
FLUOROSCOPE XRAY GE OEC MEDICAL SYSTEMS INC.:THE CUSTOMER REPORTED THAT THE CIRCUIT-BREAKER TRIPS AND THE SYSTEM HAS A DEFECTIVE TUBE. NO PT INJU
FLUOROSCOPIC X-RAY GE OEC MEDICAL SYSTEMS:IT WAS REPORTED THAT THE 6800 SYSTEM HAD MIXED UP IMAGES IN THE IMAGE DIRECTORY. NO PATIENT INJURY W
FLUOROSCOPIC X-RAY GE OEC MEDICAL SYSTEMS (SLC):IT WAS REPORTED THAT THE 9800 SYSTEM HAD A FILAMENT REGULATOR ERROR AND A PRE-CHARGE VOLTAGE ERROR M
FLUOROSCOPIC X-RAY GE OEC MEDICAL SYSTEMS INC:THE CUSTOMER REPORTED THAT THE MONITOR CART DID NOT DISPLAY AN IMAGE. THE PIN IN THE CABLE CONNECTIO
FLUOROSCOPIC X-RAY GE OEC MEDICAL SYSTEMS INC.:IT WAS REPORTED THAT THE 6800 SYSTEM WOULD NOT BOOT UP. NO PT INJURY WAS REPORTED.
FLUOROSCOPIC X-RAY GE OEC MEDICAL SYSTEMS, INC.:A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED.
FLUOROSCOPIC XRAY GE OEC MEDICAL SYSTEMS INC.:(B) (4). THE GE SERVICE REP FOUND THE CABLES WERE CAUSED BY +24V SUPPLY TO THE IMAGE INTENSIFIER HVP
FLUOROSCOPY X-RAY GE OEC MEDICAL SYSTEMS (SLC):THE CUSTOMER REPORTED THE SYS WOULD NOT TRANSITION BETWEEN AP AND LATERAL POSITIONS. BECAUSE OF THIS
FLUOROSOCPIC X-RAY GE OEC MEDICAL SYSTEMS INC:IT WAS REPORTED THAT THE 9900 SYSTEM HAD A FILE CORRUPT ERROR MESSAGE AT BOOT UP. NO PT INJURY WAS R
FLUROSCOPIC X-RAY GE OEC MEDICAL SYSTEMS INC.:A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CAMERA WAS REPLACED AND THE BEAM
FMI - NEEDLE, HYPODERMIC, SINGLE LUMEN SMITHS MEDICAL ASD, INC.:A REPORT WAS RECEIVED THAT STATED A NURSE RECEIVED A NEEDLE STICK. THE REPORT STATED THAT THE NEEDLE
FMI NEEDLE, HYPODERMIC, SINGLE LUMEN COOK INC.:THE USER FACILITY ADVISED THAT THE NEEDLE WAS INSERTED INTO THE (B) (6) FEMALE PT AND APPARENTLY BRO
FMI- NEEDLE, HYPODERMIC, SINGLE LUMEN SMITHS MEDICAL ASD, INC.:DEVICE EVALUATION: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP R
FMJ - NEEDLE, HYPODERMIC SMITHS MEDICAL ASD, INC.:CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE
FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER EDWARDS LIFESCIENCES:IN THE PROCESS OF DOING A DIALYSIS ACCESS DECLOT PROCEDURE, THE BALLOON PIECE FROM A FOGARTY CATHETE
FOLEY CATHETER ROCHESTER MEDICAL CORP.:FOLEY CATHETER BEING DISCONTINUED, BUT MULTIPLE STAFF UNABLE TO COMPLETELY DEFLATE BULB OF CATHETER.
FOLEY STABILIZATION DEVICE C.R. BARD, INC.:SINCE OUR HOSPITAL BEGAN USING THE STATLOCK FOLEY 2-WAY CATHETER STABILIZATION DEVICE, SEVERAL OF TH
FOLEY TRAY C.R. BARD INC.:PT'S FOLEY CATHETER FELL TO THE FLOOR WHEN PT WAS STANDING. INSPECTION SHOWED THAT THE BALLOON AT TH
FOR THE DETERMINATION OF BETA-HUMAN CHORIONIC GONA ABBOTT DIAGNOSTICS INT'L, LTD:THE CUSTOMER OBTAINED A NEGATIVE RESULT OF 2.44 MIU/ML FOR THE AXSYM B-HCG ASSAY FROM ONE PATIENT SA
FOR THE DETERMINATION OF BETA-HUMAN CHORIONIC GONA ABBOTT LABORATORIES:THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE
FORCEPS, BIOPSY BOSTON SCIENTIFIC CORPORATION:DURING AN ENDOSCOPY PROCEDURE, A SMALL PIECE OF FORCEPS BROKE OFF INSIDE THE PATIENT'S STOMACH. A S
FORCEPS, BIOPSY, ELECTRIC BOSTON SCIENTIFIC - COSTA RICA:DURING AN ENDOSCOPY PROCEDURE, A SMALL PIECE OF FORCEPS BROKE OFF INSIDE THE PATIENT'S STOMACH. A S
FORCEPS, BIOPSY, NON-ELECTRIC BOSTON SCIENTIFIC - COSTA RICA:NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER T
FORCEPS, CUTTING GYRUS ACMI:THE FORCEPS WOULD NOT WORK. THEY HAD NO POWER FOR COAGULATING. THE STAFF TRADED OUT CORDS AND STILL
FORCETRIAD COVIDIEN LP (VALLEYLAB):THE SITE HAS INDICATED THAT THEY WILL NOT BE RETURNING THE GENERATOR FOR EVALUATION. IF ADDITIONAL I
FORCETRIAD ENERGY PLATFORM COVIDIEN LP (VALLEYLAB):(B) (4). THE INCIDENT GENERATOR AND HANDPIECE HAVE BEEN REQUESTED, BUT TO DATE, THEY HAVE NOT BEEN R
FPA - SET, ADMIN, INTRAVASCULAR SMITHS MEDICAL MD (FORMERLY DELTEC, INC.):CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BE
FRAXEL, RESTORE RELIANT TECHNOLOGIES:I RECEIVED A FRAXEL RESTORE LASER TREATMENT AND HAVE SINCE HAD ADVERSE EFFECTS. EFFECTS INCLUDE SEVE
FREE STYLE LITE TEST STRIPS ABBOTT DIABETES CARE INC.:I KEPT RECEIVING UNUSUALLY HIGH READINGS FROM MY FREE STYLE LITE TESTING. I DOUBLED MY DOSE OF METFO
FRESHLOOKS COLOR CONTACT LENS, PLANO CIBA:CORNEAL ABRASION FROM MISUSE AND DISPENSING OF COSMETIC CONTACT LENS FROM A NON EYECARE PROFESSIONAL
FTL / MESH, SURGICAL , POLYMERIC W.L. GORE & ASSOCIATES:SAMPLE NOT RETURNED FOR EVALUATION, REVIEW OF INFORMATION PROVIDED BY THE USER. BASED UPON THE AVAIL
FTL/MESH, SURGICAL, POLYMERIC W.L. GORE & ASSOCIATES:DEVICE WAS NOT RETURNED FOR EVAL. LOT NUMBER INFO WAS NOT PROVIDED. THEREFORE, A REVIEW OF QUALITY R
FTM / MESH, SURGICAL W.L. GORE & ASSOCIATES:IT WAS REPORTED THAT ON (B) (6) 2009, A PT UNDERWENT LOW ANTERIOR RESECTION WITH DIVERTING LOOP ILEO
FTM/ MESH, SURGICAL W.L. GORE & ASSOCIATES:DEVICE WAS NOT RETURNED FOR EVALUATION. LOT NUMBER INFORMATION WAS NOT PROVIDED, THEREFORE A REVIEW
FULL BODY SCANNING SYSTEM LANE 3 UNKNOWN:PT ARRIVED AT (B) (6) AIRPORT AND ENTERED SECURITY SCREENING PRIOR TO ENTERING THE SECURE CONCOURSE.
FULLY COVERED SELF-EXPANDING METAL STENT, ESOPHAGE BOSTON SCIENTIFIC:A FULLY COVERED WALLFLEX ESOPHAGEAL STENT WAS PLACED ON (B) (6) 2009 FOR TREATMENT OF AN ANASTOMOTIC
FZP CLIP, IMPLANTABLE ETHICON ENDO-SURGERY, LLC:IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, EVERYTHING WENT FINE. VISUALLY
FZP CLIP, IMPLANTABLE ETHICON ENDO-SURGERY, LLC.:IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE JAMMED ON TISSUE. T
G2 FILTER BARD:SHE CAME TO SEE ME ABOUT A BROKEN IVC FILTER. BACK IN 2008, SHE HAD A PE WITH AN UNK ETIOLOGY. SHE T
G2X FILTER -JUGULAR/SUBCLAVIAN DELIVERY KIT BARD PERIPHERAL VASCULAR, INC.:THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBL
GAMMAKNIFE ELEKTA, AB:EMERGENCY STOP WAS ACTIVATED (DEPRESSED) WHILE GAMMAKNIFE UNIT WAS IN TREATMENT POSITON, DURING A MO
GARMENT, PROTECTIVE FOR INCONTINENCE KIMBERLY-CLARK CORP.:A (B) (6) BOY WORE DRYNITES SLEEP SHORTS FOR THE FIRST TIME AND AWOKE WITH ITCHING UNDER THE SHORTS.
GASTRIC BAND ETHICON:DURING THE CASE, THE GASTRIC BAND WAS PASSED OFF TO THE SCRUB TECHNICIAN AND THEN PLACED ON THE MAYO
GASTRIC LAP BAND ALLERGAN, INC.:LAPAROSCOPIC IMPLANT OF LAP BAND WAS IN PLACE FOR FOURTEEN MONTHS. SURGEON SAYS THERE IS LEAKING FRO
GASTROINTESTINAL MOTILITY CAPSULE THE SMARTPILL CORPORATION:(B) (4) - DEVICE LODGED BECAUSE OF PT PHYSIOLOGY.
GASTROSCOPE OLYMPUS MEDICAL SYSTEMS CORPORATION:THE USER FACILITY REPORTED TO HAVE IDENTIFIED A RECENT CLUSTER OF CLOSTRIDIUM DIFFICILE AMONG NINE P
GASTROSCOPE #126 FUJINON INC.:FUJINON GASTROSCOPE #126 WAS SENT IN FOR REPAIRS DUE TO SCOPE WOULD NOT TAKE PICTURES, GASTROSCOPE #
GASTROSTOMY TUBE CORPAK MEDSYSTEMS:THE DILATING PORTION OF THE PEG TUBE BECAME DISCONNECTED DURING THE PLACEMENT PROCEDURE. ALL OF THE
GASTROSTOMY TUBE, 18F MOSS TUBES, INC.:TUBE FEEDING CONNECTED TO G TUBE PORT INSTEAD OF J TUBE PORT.
GAUZE, STERILE COVIDIEN:STERILE PROCESSING DEPARTMENT TECHNICIAN OBSERVED DEFECTIVE STERILE PACKAGING ON A NUMBER OF INDIVID
GCB CATHETER NEEDLE COOK, INC.:(B) (4). EVAL: NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. UNFORTUNATELY, WITHOUT THE A
GCJ LAPAROSCOPE, GENERAL AND PLASTIC SURGERY ETHICON ENDO-SURGERY, LLC:IT WAS REPORTED THAT DURING AN UNKNOWN CASE, THE TROCAR WAS BEING USED UNDER OPTICAL ENTRY. DURING E
GCJ LAPAROSOCPE, GENERAL AND PLASTIC SURGERY ETHICON ENDO-SURGERY, LLC:IT WAS REPORTED THAT IN (B) (6) 2009 THE DEVICE WAS USED DURING A LAPAROSCOPIC PROCEDURE. DURING THE
GDW STAPLE, IMPLANTABLE ETHICON ENDO-SURGERY, LLC:IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE SURGEON FIRED THE DEVICE ACROSS THE STOM
GDW STAPLE, IMPLANTABLE ETHICON ENDO-SURGERY, LLC.:IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, THE STAPLER CLOSED AS N
GEI - ELECTROSURGICAL, CUTTING & COAGULATION & MEDTRONIC XOMED INSTRUMENTATION:MEDTRONIC IN (B) (4) REPORTED THAT THE (B) (4) AND (B) (6) HOSPITAL, REPORTED TO THE (B) (4) ON JAN
GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCES ETHICON ENDO-SURGERY, LLC:INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
GEI, ELECTROSURGICAL SYSTEM ARAGON SURGICAL:THE PATIENT IS FINE, THE CONCLUSION ON THE BEHALF OF ARAGON SURGICAL IS THAT THE INFORMATION DOES WA
GEMSTAR HOSPIRA:PT CALLED NURSE ON CALL THAT HER TPN PUMP STARTED ALARMING AT 0150 SAYING "CODE CALL." PT STARTED TP
GENERAL INSTRUMENT MEDTRONIC SOFAMOR DANEK:A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL PRODUCT I
GENERATOR, ABLATION, CARDIAC BOSTON SCIENTIFIC:THE PATIENT UNDERWENT MONITORED ANESTHESIA CARE (MAC) SEDATION AND ALL THE PREPARATORY STEPS FOR THE
GI BANDER WILSON-COOK MEDICAL:PT WAS ADMITTED WITH ESOPHAGEAL VARICES AND UNDERWENT AN EGD WITH ESOPHAGEAL BANDING. THE ENDOSCOPE
GIA REUSABLE STAPLER NORTH HAVEN - USS:PROCEDURE TYPE: COLECTOMY. ACCORDING TO THE REPORTER: THE STAPLER GOT CAUGHT ON THE TISSUE AND COULD
GII A/P CUTTING BLOCK/LXH SMITH & NEPHEW, INC., ORTHOPAEDIC DIVISION:NA
GIVEN MEDTRONIC BRAVO PH RECEIVER GIVEN IMAGING:THE PT CAME IN FOR A BRAVO PH PROCEDURE. THE EXAM WAS COMPLETED SUCCESSFULLY AND THE PT LEFT WITH TH
GLENOID BASEPLATE TORNIER:THE SURGEON WAS PERFORMING A SHOULDER REPLACEMENT. HE WAS UNABLE TO LOCK TWO COMPONENTS TOGETHER AS
GLENOID BASEPLATE LINER ENCORE MEDICAL, L.P.:THE (B) (4) SURGICAL MARKETING TEAM WAS CONTACTED BY A SURGEON WHO STATED THAT HE HAD A PATIENT THAT
GLENOID SPHERE TORNIER:THE SURGEON WAS PERFORMING A SHOULDER REPLACEMENT. HE WAS UNABLE TO LOCK TWO COMPONENTS TOGETHER AS
GLIDESCOPE VERATHON MEDICAL:THE PATIENT EXPERIENCED A PALATE TEAR AFTER THE USE OF THE GLIDESCOPE FOR ENDOTRACHEAL INTUBATION. T
GLIDEWIRE BOSTON SCIENTIFIC MICOVASIVE:FRAGMENTS OF THE GLIDEWIRE WERE RETAINED PLACING A CENTRAL LINE FOR THE NEONATE. DATES OF USE: (B) (
GLIDEWIRE TERUMO:DEVICE NOT MANUFACTURED BY ENDOLOGIX. GLIDEWIRE IS MANUFACTURED BY TERUMO; DEVICE MANUFACTURING FAC
GLOVES ANSELL DERMA:GREEN STERILE SURGICAL GLOVES DISCOLORED WITH BLACK SPLOTCHES.WERE NOT USED ON PATIENT.
GLUCOE MONITORING SYS/KIT LIFESCAN, INC.:LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE
GLUCOSE MONITORING SYS/KIT LIFESCAN, INC.:ON (B) (6) 2010, THE LAY USER / PT'S SON CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PT'S ONE TOUCH U
GLUCOSE MONIOTRING SYS/KIT LIFESCAN, INC.:THE LAY USER / PT CONTACTED LFS ON (B) (6) 2010, ALLEGING INACCURATE HIGH READINGS ON HIS ONE TOUCH
GLUCOSE MONITORIGN SYS/KIT LIFESCAN, INC.:LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE
GLUCOSE MONITORING KIT LIFESCAN, INC.:THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE CONTROL SOLUTION TEST RESULTS ARE INACCURATELY
GLUCOSE MONITORING SY/KIT LIFESCAN, INC.:LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE
GLUCOSE MONITORING SYS/KIT LIFESCAN, INC:ON (B) (6) 2010, THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) TO REPORT THE ONE TOUCH ULTRA METER
GLUCOSE MONITORING SYS/KIT LIFESCAN, INC.:LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVAL. IF THE PRODUCT(S) ARE RETURN
GLUCOSE MONITORING SYS/KIT (NBW) LIFESCAN, INC.:LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE
GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC.:THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DOES NOT POWER ON. THE ISSUE WAS NOT RESO
GLUCOSE MONITORING SYSTEM LIFESCAN, INC.:LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCTS FOR EVALUATION. IF THE PRODUCTS ARE RETU
GLUCOSE MONTIROING SYS/KIT LIFESCAN, INC.:ON JANUARY 13, 2010, THE LAY PATIENT CONTACTED LIFESCAN ALLEGING THAT HER ONE TOUCH ULTRA MINI METER
GLUCOSE SENSOR MEDTRONIC MINIMED:THE CUSTOMER CALLED TO REPORT THAT THE PARAMEDICS WERE CALLED TO HER HOME DUE TO A BLOOD GLUCOSE REA
GLUOSE MONITORING SYS/KIT LIFESCAN, INC.:LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE
GOOSENECK EXAM LAMP GOODWIN MANUFACTURING, INC.:THE FACILITY BOUGHT A NEW GOOSENECK MEDI CHOICE EXAM LAMP FROM OWENS & MINOR. THE LABELING ON THE BO
GOWN, SURGICAL KIMBERLY-CLARK CORP.:THE PHYSICIAN'S ASSISTANT WAS WEARING THE GOWN DURING A LEFT TOTAL KNEE ARTHROPLASTY AND REPORTED A
GRAFTON ALLOGENIC, BONE MATRIX CORIN USA:I AM HAVING NECK, SHOULDER AND LEFT ARM PAIN. I ALSO HAVE MIGRAINE AND SINUS HEADACHES, SWELLING OF
GRASPER CAREFUSION:JUST FOLLOWING UP ON CONCERNS BY DR (B) (6) REGARDING THE USE OF THE "REVISED" TEAR DROP BABCOCK. HE
GRASPER RICHARD WOLF MEDICAL INSTRUMENTS CORP.:WHILE USING LAPAROSCOPIC GRASPER, THE "JAW" BROKE OFF INSIDE THE PATIENT. PIECE WAS RETRIEVED AND AC
GRASPING FORCEPS SMITH & NEPHEW, INC. ENDOSCOPY DIVISION:THIS PATIENT WAS SCHEDULED FOR A RIGHT ANKLE ARTHROSCOPY. THE SURGEON WAS ATTEMPTING TO REMOVE A LO
GREAT TOE IMPLANT OSTEOMED L.P.:PATIENT RECEIVED REFLEXION TOE IMPLANT ON (B) (6) 2009. AFTER SURGERY PATIENT HAD SWELLING WITH REDN
GROSHONG POWERPORT 8 FR. BARD ACCESS SYSTEMS, INC.:PROBLEMS: USER ERROR - NEITHER THE SURGEON NOR THE OR STAFF RECOGNIZED THAT A STYLET WAS ENCASED INS
GROUND PAD CONMED CORPORATION:IT WAS REPORTED THAT "POST-OP THE FAMILY NOTICED SEVERAL SMALL BURNS ON THE DORSAL SURFACE OF THE RI
GUIDE WIRE ABBOTT VASCULAR:WHILE ADVANCING HI-TORQUE FLOPPY WIRE THRU STENT TO DISTAL VESSEL, WIRE TIP FROM GUIDE WIRE CAUGHT O
GUIDE WIRE MEDTRONIC, INC.:IT WAS REPORTED WHEN PLACING THE LV LEAD, THE ATTAIN HYBRID WIRE WAS POSITIONED IN THE VESSEL. THE D
GUIDE, ORTHOPEDIC BIOMET ORTHOPEDICS:IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE ARTHROPLASTY PROCEDURE UTILIZING INSTRUMENTATION GUIDE
GUIDED NAVIGATION SYSTEM MEDTRONIC NAVIGATION:ABORTED CRANIOTOMY FOR BIOPSY OF TUMOR DUE TO FAILURE OF GUIDED IMAGERY UNIT (STEALTH). UNABLE TO PE
GUIDEWIRE ABBOTT VASCULAR:AFTER DEPLOYING 7 X 120 X 120 EVERFLEX STENT, THE DISTAL TIP OF THE STENT CATHETER GOT STUCK ON THE
GUIDEWIRE BOSTON SCIENTIFIC:AT THE END OF AN ANGIOPLASTY/STENTING PROCEDURE, APPROXIMATELY 12MM PIECE OF RADIOPAQUE GUIDEWIRE BR
GUIDEWIRE BOSTON SCIENTIFIC CORPORATION:GLIDEWIRE SENT UP TO PT'S LEFT URETER WITH URETEROSCOPE. WHEN WIRE REMOVED, THE COATING TO THE WIRE
GUIDEWIRE ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION:IT WAS REPORTED THAT DURING IMPLANT, DUE TO THE ACUTE ANGLE BEND OF THE VEIN THE GUIDEWIRE TURNED BA
GUIDEWIRE, 3 CM FLEXIBLE TIP COOK UROLOGICAL, INC.:THE PT HAD A CYSTOSCOPY WITH LEFT URETERAL DILATION USING A COAXIAL URETERAL SHEATH, AND A LEFT FLEX
GUIDEWIRE, COPE MANDRIL COOK MEDICAL INCORPORATED:EVENT OCCURRED DURING INTERVENTIONAL RADIOLOGY PROCEDURE (COMPLEX CORONARY HEART DISEASE PATIENT) FO
GUIDEWIRE, CORONARY ABBOTT LABORATORIES:PHYSICIAN PERFORMING A SELECTIVE RIGHT CORONARY ARTERY ANGIOGRAPHY WITH PLACEMENT OF OVERLAPPING DRU
GYRUS SHAVER 3.0MM BIPOLAR TURBINATE DISSECTOR BLA ACMI GYRUS:MD STARTED USING THE PK DISSECTOR BLADE AND FOUND THAT THE TIP IS BROKEN.
HAKIM VENTRICULAR & PERITONEAL CATHETERS WITH BACT CODMAN & SHURTLEFF, INC.:AFFILIATE REPORTED THAT THE PT DEVELOPED AN INFECTION. THE PT WAS TREATED WITH ANTIBIOTICS AND RECOV
HAMONIC SCAPEL ACE363 ETHICON:HARMONIC SCAPEL MINIMUM ENERGY BUTTON WOULD NOT WORK.
HANDPIECE, ENDOSCOPIC VESSEL HARVESTING SYSTEM MAQUET CARDIOVASCULAR:THE VASOVIEW DEVICE WAS DEPLOYED IN THE PATIENT'S LEG. DURING FIRING OF THE DEVICE THE ACTIVATION T
HANDPIECE, ESU, ARGON BEAM ERBE:AFTER INCISION, THE ERBE ARGON TIP BROKE OFF. SURGEONS WERE ABLE TO RETRIEVE THE PIECE AND IT APPEA
HANDPIECE, ESU, COBLATION ARTHROCARE:ARTHROCARE COBLATOR II BEGAN TO SMOKE AND WAS NOT COAGULATING EFFECTIVELY PER SURGEON.
HANDPIECE, ESU, SUCTION/COAGULATION ARTHROCARE:ARTHROCARE SUPER TURBOVAC 90 WITH INTEGRATED CABLE, RESTERILIZED BY ASCENT MALFUNCTIONED DURING CASE
HANDPIECE, ESU, VESSEL SEALING VALLEY LAB:DEVICE FAILED TO WORK. IT WAS PLUGGED IN AND WOULD NOT RESPOND TO ANYTHING. THE DEVICE WOULD NEVER T
HANDPIECE, ESU, VESSEL SEALING VALLEYLAB:DURING USE OF EQUIPMENT, IT LOCKED AND WAS NO LONGER USABLE. THE HAND PIECE WAS REPLACED WITH A NEW
HANDPIECE, LASER, OPHTHALMIC IRIDEX CORPORATION:LASER PROBE HANDED OFF TO THE FIELD."DO NOT RECOGNIZE THIS PROBE", ERROR MESSAGE OCCURRED AFTER PROB
HANDPIECE, ULTRASONIC ETHICON:PATIENT UNDERGOING PARATHYROID EXPLORATION AND LEFT INFERIOR PARATHYROIDECTOMY. DURING THE SURGERY,
HARD RODS SYNTHES BRANDYWINE:PT STATUS POST T8-10 CORPECTOMY, IMPLANTED WITH DUAL OPENING SCREW AND RODS T5-T7 AND USS SCREWS T11
HARDWARE, ORTHOPEDIC, 9 HOLE WIDE LEFT PLATE DEPUY ORTHOPAEDICS, INC.:PT ORIGINALLY HAD HARDWARE PLATE FOR AN ANKLE FRACTURE. DURING HIS POST OPERATIVE COURSE, THE HARDWA
HARDWARE, SPINAL, CERVICAL FUSION K2M, INC.:APPROXIMATELY EIGHT MONTHS AGO, THE PATIENT UNDERWENT AN UNEVENTFUL ANTERIOR CERVICAL MICRODISCECTOM
HARMONIC ETHICON:DURING A COLON RESECTION, THE HARMONIC SCALPEL HAND-HELD HANDPIECE, MADE ALL THE SOUNDS OF FUNCTIONI
HARMONIC CURVED SHEARS ETHICON ENDO-SURGERY, INC.:THE 36CM HARMONIC CURVED SHEARS WERE CONNECTED TO THE GENERATOR AND KEPT ALARMING, INDICATING A PROB
HARMONIC SCALPEL ASCENT:THE MAX BUTTON WOULD NOT WORK WHEN PRESSED.
HARMONIC SCALPEL ETHICON:INSULATION CAME OFF THE BLADE OF THE HARMONIC SCALPEL. ALL PIECES WERE RETREIVED. NO HARM TO THE PAT
HARMONIC SCALPEL ETHICON ENDO-SURGERY INC:THE PATIENT WAS HAVING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PERFORMED BY ONE DOCTOR, ASSISTED B
HARMONIC SHEARS ETHICON ENDO SURGERY INC.:ETHICON HARMONIC SHEARS MALFUNCTIONED, FIVE ATTEMPTS OF DISASSEMBLE, REASSEMBLY, AND REBOOTING MACHI
HARVESTING CANNULA MAQUET CARDIOVASCULAR, LLC:THE DEVICE WAS RETURNED TO CARDIAC SURGERY ON 22 JAN 2010 FOR INVESTIGATION. A SUPPLEMENTAL REPORT W
HAW (STEREOTAXIC INSTRUMENT) ZIMMER CAS:THE USE OF THE DEVICE IN FURTHER SURGERIES WAS STOPPED AND A REPLACEMENT TRACKING CAMERA SENT TO THE
HBB - MOTOR, DRILL, PNEUMATIC MEDTRONIC POWERED SURGICAL SOLUTIONS:REPORT CONFIRMED. EVAL OF THE AF02 DETERMINED THAT THE FOOTED PORTION WAS DAMAGED BY TOOL CONTACT. T
HBE - DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMP MEDTRONIC POWERED SURGICAL SOLUTIONS:REPORT CONFIRMED. THE TOOL HAS NOT BEEN RETURNED FOR EVALUATION BUT WAS CONFIRMED UPON RETRIEVAL TO
HBO CHAMBER SECHRIST INDUSTRIES:PATIENT HAVING HBO TREATMENT FOR RIGHT FOOT OSTEOMYELITIS, S/P METATARSAL AMPUTATION. PATIENT DEVELO
HD SURGICAL SYSTEM INTUITIVE SURGICAL:DURING A PROSTATECTOMY CASE, THE SECOND ARM ON THE DAVINCI FAULTED ACCORDING TO THE PHYSICIAN TRYING
HEAD / JDH SMITH & NEPHEW ORTHOPAEDICS:REVISION SURGERY WAS REPORTED DUE TO WEAR.
HEART VALVE ST JUDE:JUDE VALVE IMPLANTED. CAME OFF CP BYPASS. TRANSVALVULAR AORTIC INSUFFICIENCY NOTED BY (B) (6). WENT
HEAT & MOIOSTURE EXCHANGER PALL NEWQUAY:IT WAS REPORTED THAT DURING A UNUSUALLY LONG SURGICAL PROCEDURE, THE DEVICES PLACED AT THE MACHINE E
HEAT & MOISTURE EXCHANGER PALL NEWQUAY:ON THE SUBSEQUENT DAY TO THE EVENT REPORTS AS (9680602-2010-00002) IT WAS REPORTED THAT DURING A SUR
HEAT THERAPY PUMP GAYMAR INDUSTRIES:HEAT THERAPY PUMP (KPAD) WAS APPLIED TO PATIENT'S RIGHT KNEE. THE PATIENT ALSO HAD A LIDODERM PATCH
HEAT TREAT MEDICAL WARMING BLANKET APRICITY LLC:HEAT TREAT BLANKET IN USE PRE-OPERATIVELY AND INTRA-OPERATIVELY TO ASSIST WITH NORMOTHERMIA. DISCOVE
HEATED CIRCUIT TELEFLEX MEDICAL:THE EVENT IS REPORTED AS: COMPLAINT INDICATES THAT AN ALLEGED DEATH OCCURRED DUE TO A MUCUS PLUG. CO
HEATER TELEFLEX MEDICAL:ON JANUARY 12, 2010, THE MANAGER OF RESPIRATORY THERAPY REC'D A RECALL NOTICED FOR THE CONCHATHERM N
HEATING PAD JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS:CONSUMER ALLEGES THAT A HEATING PAD CAUSED BURNS TO HER ARM. PHOTOGRAPHS SUGGEST SHE SUSTAINED A 3RD
HEATING PAD KAZ INC:CONSUMER STATES SHE MICROWAVED THE HEATING PAD IN ACCORDANCE WITH THE INSTRUCTIONS. WHEN SHE REMOVED
HEATING PAD TEAMEDICS MANUFACTURING CO. LTD.:HP-INJURY-BURN. RECEIVED NOTICE FROM (B) (4), ON BEHALF OF (B) (4) IN REGARDS TO A CONSUMER BEING IN
HEB - UNSCENTED MENSTRUAL TAMPON KIMBERLY-CLARK CORP - CONWAY MILL:SAMPLES ARE BEING INSPECTED. CONSUMER HAS FOLLOW UP WITH PHYSICIAN.
HEMATOLOGY ANALYZER SYSMEX AMERICA, INC:CBC (COMPLETE BLOOD COUNT) PRINTOUT FROM SYSMEX XE-2100 HEMATOLOGY ANALYZER HAD PATIENT DEMOGRAPHICS
HEMI-KNEE PROSTHESIS - HSH ABS CORPORATION:THE INITIAL REPORTER INDICATED THE EVENT WAS DEVICE RELATED; HOWEVER, THERE WAS NO ADDITIONAL INFORM
HEMMODIALYSIS CATHETER MEDCOMP:IT WAS REPORTED THAT DURING THE DIALYSIS TREATMENT, THE NURSE NOTICED A LEAK IN THE VENOUS SIDE OF T
HEMODIALYSIS BLOOD TUBING SET MEDISYSTEMS CORP.:SINCE THE COMPLAINT SAMPLE WAS DISCARDED AND LOT NUMBER WAS NOT KNOWN, NO LOT SPECIFIC INVESTIGATION
HEMODIALYSIS CATHETER COVIDIEN:(B) (4). AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
HEMODIALYSIS CATHETER MEDCOMP:AN INVESTIGATION HAS BEEN INITIATED. WE HAVE RECEIVED PART OF THE INVOLVED DEVICE FOR EVALUATION. WE
HEMODIALYSIS MACHINE B. BRAUN MEDICAL, INC.:DURING VISUAL INSPECTION OF OPERATIONAL MACHINES, A B. BRAUN CUSTOMER SERVICE ENGINEER NOTICED A PT
HEMODIALYSIS MACHINE, CONTINOUS RENAL REPLACEMENT GAMBRO RENAL PRODUCTS, INC.:THE DIALYSATE BAG WAS CHANGED AND FIVE MINUTES LATER THERE WAS AN EXCESS FLUID LOSS/GAIN ALARM SOUND
HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACEMENT GAMBRO RENAL PRODUCTS, INC:WHILE RUNNING THE CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY MACHINE), IT STOPPED AND GAVE AN ERROR
HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACEMENT GAMBRO RENAL PRODUCTS, INC.:FILTER CHANGE DUE. THERAPY WAS STOPPED, AND THE SAME PATIENT WAS SELECTED. PRIMING PROCEDURE INITIAT
HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACMENT GAMBRO RENAL PRODUCTS, INC.:WHILE CHANGING THE EFFLUENT DRAINAGE BAG, THE COMPUTER SCREEN ON THE PRISMAFLEX CRRT (CONTINUOUS REN
HEMODIALYSIS SYSTEM B. BRAUN MEDICAL, INC.:THE EXACT CAUSE OF DEATH HAS NOT BEEN DETERMINED BY THE FACILITY. HOWEVER, IT IS BELIEVED THE CAUSE
HEMODIALYSIS SYSTEM EDWARDS LIFESCIENCES:AFTER STARTING THE HEMODIALYSIS SYSTEM, THE DEGASSING ALARM SOUNDED, AND TROUBLESHOOTING EFFORTS WER
HEMODIALYSIS, CONTINUOUS RENAL REPLACE THERAPY GAMBRO RENAL PRODUCTS:THE EFFLUENT DRAIN BAG WAS CHANGED ON MACHINE AROUND MIDNIGHT. MACHINE FLIPS HOUR ABOUT 10 MINUTES
HEMODIALYSIS, CRRT GAMBRO AMERICAN:THE CRRT MACHINE WAS IN USE ON THE PT. THERE WAS NO BLOOD PUMPING FROM THE PT AND CITRATE FILLED HAL
HEMODIALYSIS, CRRT GAMBRO RENAL PRODUCTS:GAMBRO PRISMAFLEX SUDDENLY ALARMED AIR DETECTED THEN IT GAVE MESSAGE STOP TREATMENT AND CALL FOR SER
HEMOFLOW F8 FRESENIUS MEDICAL CARE NORTH AMERICA:HEMODIALYSIS FILTER AND LINES SET UP PER PROTOCOL. HEMODIALYSIS INITIATED. "BLOOD LEAK" ALARM SOUNDE
HEMOPRO MAQUET CARDIOVASCULAR, LLC:THE HOSPITAL REPORTED A SERIOUS INJURY THAT OCCURRED DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE
HEMOPRO DC CABLE MAQUET CARDIOVASCULAR, LLC:ADDITIONAL INFORMATION IS BEING REQUESTED TO CLOSE THIS INVESTIGATION. WE WILL CONTINUE TO PURSUE AD
HEMOPRO DISSECTION TIP MAQUET CARDIOVASCULAR, LLC.:THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO DISSECTION TI
HEMOPRO DISSECTION TIP MAQUET PUERTO RICO, LLC:(B) (4) RECEIVED THE DEVICE ON 01/20/2010. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIG
HEMOPRO TISSUE WELDER MAQUET CARDIOVASCUALR, LLC:INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED TO CARDIAC SURGERY ON FEB 19, 2010, FOR INVESTIGATION
HEMOPRO TISSUE WELDER MAQUET CARDIOVASCULAR, LLC:THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VH-3000 HEMOPRO WOULD
HEMOPRO TISSUE WELDER MAQUET CARDIOVASCULAR, LLC.:INVESTIGATION RESULTS: MAQUET CARDIOVASCULAR RECEIVED THE DEVICE ON 01/29/2010. THE VISUAL INSPECTIO
HEMOSTASIS DEVICE ANGIOTECH:AT END OF PROCEDURE AND HEMOSTASIS TO RIGHT GROIN PUNCTURE, DOCTOR NOTED AREA OF DENUDED WHITE/GRAY
HEMOSTATIC AGENT, ABSORBABLE ETHICON, INC.:IT WAS REPORTED THAT A PT UNDERWENT OPEN CHEST SURGERY IN 2009. DURING THE PROCEDURE, THERE WAS BLEE
HEMOSTATIC MATRIX BAXTER:POSSIBLE ADVERSE REACTION TO PRODUCT USED IN SURGERY; FLOSEAL HEMOSTATIC MATRIX. RESULTED IN BOWEL R
HEPARIN PREFILL COVIDIEN:AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
HERNIA MESH BARD:MY MOM HAD HERNIA SURGERY (B) (6) 2007 PASSED AWAY (B) (6) 2008. I AM AN RN. I AM VERY AWARE OF WHAT
HERNIA PATCH UNK:SURGERY TO FIX HERNIA. AFTER BEING RELEASED FROM DOCTOR'S CARE, I STILL HURT WORSE THAN BEFORE SURGE
HEX DRIVER ACUMED LLC:PT WAS HAVING AN ORIF (OPEN REDUCTION INTERNAL FIXATION) OF THE LEFT ELBOW. A MINI ACUTRAK SCREW WA
HIGH FREQUENCY CABLE OLYMPUS WINTER & IBE GMBH:THE USER FACILITY REPORTED TO HAVE OBSERVED SMOKE COMING FROM THE DISTAL PORTION OF THE CABLE UPON T
HIGH FREQUENCY CABLE OLYMPUS WINTER AND IBE GMBH:OLYMPUS HAD FOLLOWED UP WITH THE USER FACILITY TO GATHER ADDITIONAL INFORMATION. THE HIGH FREQUENCY
HIGH FREQUENCY ELECTRODE OLYMPUS WINTER & IBE GMBH:THE USER FACILITY REPORTED BURNS HAVING BEEN OBSERVED ON A PT'S LIVER DURING A THERAPEUTIC LAPAROSCO
HIGH PERMEABILITY HEMODIALYSIS SYSTEM NXSTAGE MEDICAL, INC.:EVALUATION OF THE RETURNED CARTRIDGE CONFIRMED A CRACK OCCURRED IN THE ARTERIAL CAP ON THE FILTER. R
HIGH VISCOSITY, RADIOPAQUE BONE CEMENT MEDTRONIC SPINCE LLC:DEVICE NOT RETURNED, FOLLOW UP WITH COMPANY REP.
HIGH VISCOSITY, RADIOPAQUE BONE CEMENT MEDTRONIC SPINE LLC:REPORT SOURCE: ARTICLE TITLED, "VERTEBRAL OSTEITIS ADJACENT TO KYPHOPLASTY" BY DANIEL WENDLING, MICH
HIGH VISCOSITY, RADIOPAQUE BONE CEMENT MEDTRONIC SPINE LLC.:DEVICE NOT RETURNED, FOLLOW UP WITH COMPANY REP.
HIGH VISCOSITY, RADIOPAQUE BONE CEMENT MEDTRONIC SPINE, LLC.:IN AN ARTICLE TITLED "VERTEBRAL OSTEITIS ADJACENT TO KYPHOPLASTY", THE FOLLOWING EVENT WAS REPORTED:
HIP BALL STRYKER HOWMEDICA:STRYKER TRIDENT CERAMIC HIP IMPLANT DONE FOR SECOND TIME FOR REVISION SURGERY FOR NORMAL WEAR AND TE
HIP COMPONENT WRIGHT MEDICAL TECHNOLOGY:THREE YEARS AGO PATIENT HAD A RESURFACING RIGHT TOTAL HIP ARTHROPLASTY. SHE DID WELL FOR A FEW YEAR
HIP COMPONENT WRIGHT MEDICAL TECHNOLOGY, INC.:INVESTIGATION IS NOT COMPLETED. TRENDS WILL BE EVALUATED. THE EVENT DEVICE CODE IS ADDRESSED IN THE
HIP INSTRUMENT ZIMMER, INC.:(B) (4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
HIP PROSTHESIS DEPUY FRANCE S.A.:NO 510K# SUBMITTED AS DEPUY ORTHOPAEDICS SELLS A SIMILAR PRODUCT (OR THE SAME PRODUCT WITH A DIFFERE
HIP PROSTHESIS ZIMMER MANUFACTURING B.V.:EVAL SUMMARY - NO PRODUCT WAS RETURNED AS IT REMAINS IN THE PT. IT IS UNK WHETHER PROPER SURGICAL TE
HIP PROSTHESIS ZIMMER, INC.:THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
HLA SOFTWARE HKS MEDICAL INFO SYSTEMS:HLA SOFTWARE SYSTEM WITHOUT ANY DOCUMENTATION THAT PERFORMS HLA MATCH CALCULATIONS AND REPORTING. UN
HO:YAG SURGICAL LASER DELIVERY DEVICE:DUO TOME LUMENIS LTD. YOKNEAM:IT WAS REPORTED THAT A PT DIED FOLLOWING A HOLAP PROCEDURE USING A LUMENIS PRODUCT. IT WAS FURTHER R
HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) INTEGRA LIFESCIENCES:HEADHOLDER, INTEGRA MAYFIELD A 1059, SLIPPED AS SURGEON WAS TURNING THE PATIENT. PATIENT'S HEAD WAS
HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) INTEGRA LIFESCIENCES CORPORATION:PATIENT WAS UNDERGOING AWAKE BILATERAL DEEP BRAIN STIMULATOR PLACEMENT. WHILE TRYING TO PLACE THE E
HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) INTEGRA NEUROSCIENCES:PATIENT SCHEDULED FOR POSTERIOR CERVICAL FUSION. MAYFIELD 3 POINT HEADREST WAS APPLIED. WHEN PATIE
HOLMIUM LASER FIBER AMERICAN MEDICAL SYSTEMS, INC.:LASER FIBER BROKE INTRAOPERATIVELY. TWO FIBERS MALFUNCTIONED. THE FIRST ONE BROKE - THE BROKEN PIECE
HOMEPUMP I-FLOW CORPORATION:PT CONNECTED TO CHEMO-2200 MG OF 5 FU OVER 46 HOURS VIA I-FLOW HOMEPUMP C-SERIES- IN 2009 AT 3:30 PM
HOOK WARSAW ORTHOPEDIC INC.:(B) (4). LITERATURE ARTICLE CITATION: RICHARDS ET AL. DELAYED INFECTIONS AFTER POSTERIOR TSRH SPINAL
HOOK INSTRUMENTATION WARSAW ORTHOPEDIC INC.:IT WAS REPORTED THAT A PT UNDERWENT A POSTERIOR CORRECTION AND FUSION WITH SEGMENTAL HOOK INSTRUMENT
HOOK, RODS, SCREWS MEDTRONIC SOFAMOR DANEK:(B) (4). LITERATURE ARTICLE CITATION: RICHARDS ET AL, DELAYED INFECTIONS AFTER POSTERIOR TSRH SPINAL
HOOKS SYNTHES (USA):ADD'L INFO HAS BEEN REQUESTED. SYNTHES IS UNABLE TO PROVIDE THE DATE OF MANUFACTURE WITHOUT A LOT NU
HOOKS RODS, SCREWS MEDTRONIC SOFAMOR DANEK:(B) (4). LITERATURE ARTICLE CITATION: RICHARDS ET AL. DELAYED INFECTIONS AFTER POSTERIOR TRSH SPINAL
HOOKS, RODS, SCREWS MEDTRONIC SOFAMOR DANEK:(B) (4) - FLUCTUANCE. . LITERATURE ARTICLE CITATION: RICHARDS ET AL. DELAYED INFECTIONS AFTER POSTER
HOOKS, RODS, SCREWS WARSAW ORTHOPAEDIC INC.:(B) (4) - PSEUDARTHROSIS. LITERATURE ARTICLE CITATION: RICHARDS ET AL. DELAYED INFECTIONS AFTER POST
HOOKS, RODS, SCREWS WARSAW ORTHOPEDIC INC.:(B) (4). LITERATURE ARTICLE CITATION: RICHARDS ET AL. DELAYED INFECTIONS AFTER POSTERIOR TSRH SPINAL
HOOKS/CROSSLINKS MEDTRONIC SOFAMOR DANEK:(B) (4). LITERATURE ARTICLE CITATION: RICHARDS ET AL. DELAYED INFECTIONS AFTER POSTERIOR TSRH SPINAL
HOSPITAL BED GRAHAM FIELD HEALTH PRODUCTS:PT WAS IN BED WITH THE BED IN THE HIGHEST POSITION. THE PT'S DAUGHTER, USING THE BED CONTROLS, TRIED
HOSPITAL BED HILL-ROM, INC.:THE BED CONTROLS WOULD NOT OPERATE THE BED. ALL MOTORS WERE LOCKED OUT. THE BED WAS FLAT AND THE PAT
HOSPITAL BED INVACARE CORPORATION:THE LEFT SIDE OF THE HEADBOARD BROKE APART FROM THE HOSPITAL BED AND CRANK FELL OFF. THE PATIENT WA
HOSPITAL BED STRYKER MEDICAL:UNOCCUPIED BED SENT TO BIOENGINEERING FOR NOT HOLDING A CHARGE. MANUFACTURER RESPONSE (AS PER REPORT
HOSPITAL BED, A-C POWERED, ADJUSTABLE STRYKER MEDICAL QUEBEC, LP:IT WAS REPORTED, THROUGH A NEWSPAPER ARTICLE, THAT A PATIENT WAS FOUND DEAD BY NURSE IN 2009. IT WAS
HOSPITAL WHEELED STRETCHER STRYKER CORP, MEDICAL DIVISION:IT WAS REPORTED HYDRAULIC JACK WAS UNABLE TO BE RAISED. NO ADVERSE CONSEQUENCES ARE ALLEGED.
HOSPITAL WHEELED STRETCHER STRYKER CORP., MEDICAL DIVISION:IT WAS REPORTED A PT FELL OFF THE STRETCHER WHILE ATTEMPTING TO TURN OVER. THE USER FACILITY DID NOT
HOSPITAL WHEELED STRETCHER STRYKER MEDICAL KALAMAZOO:(B) (4) OF THE OPERATIONS MANUAL STATES THE FOLLOWING: OPERATION OF THE PNEUMATIC FOWLER IS A MANUAL
HOT DRY AIR/FLUIDIZED MEDIUM UNIT CHATTANOOGA CORP.:HOT DRY AIR / FLUIDIZED UNIT USED ON PH ARM. PH C/O HOT AND BURNING. ARM RED. NO BLISTER ICE APPLIED
HOT PACK MEDLINE:STAFF MEMBER WAS ACTIVATING ONE OF THE ACCU-THERM HOT PACKS FOR A PT. HE TORE OPEN THE BOTTOM ON THE
HOYER DISPOSABLE SLING LIFT - MEDIUM JOERNS HEALTHCARE, INC.:PT WAS BEING TRANSFERRED FROM BED TO CHAIR USING A HOYER LIFT. THE PT SLING BEGAN TO TEAR AND RIP. T
HOYER LIFT MEDLINE INDUSTRIES, INC.:THIS VOLUNTARY REPORT CONCERNS THE MALFUNCTION OF THE POWER CHARGING COMPONENT OF A HOYER LIFT MEDIC
HPERDERMIC NEEDLE SURGICAL NEEDLE MANUFACTURER:BODY TEMPERATURE ELEVATED, BLOOD PRESSURE ELEVATED, WENT UP AND THEN CAME DOWN. MUST KEEP TAKING CLO
HS III PROXIMAL SEAL MAQUET CARDIOVASCULAR, LLC:THE DEVICE HAS NOT YET BEEN RETURNED TO CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE TO PURSU
HUBER NEEDLE SMITHS MEDICAL ASD:UPON NURSE REMOVING HUBER NEEDLE, NEEDLE PULLED COMPLETELY BACK OUT OF SAFETY DEVICE. NEEDLE PULLED
HUMANOPTICS DR. SCHMIDT INTRAOCULARLINSEN:IMPLANT IRIS REPOSITIONING, RIGHT EYE. THE DEVICE MIGRATED OUT OF THE CAPSULAR BAG AND BECAME UNSTAB
HUMERAL STEM/HSD AARAU SWITZERLAND MANUFACTURING SITE:IT WAS REPORTED THAT THE STEM WAS CROSS THREADED DURING INSERTION, EXTENDING SURGERY TIME BY APPROXI
HUMIDAIRE 3I RESMED LTD.:A PATIENT REPORTED TO RESMED THAT THEY CUT THEIR CHIN BY FALLING OUT OF THEIR BED AND ONTO THEIR CPA
HUMIDIFIER TELEFLEX MEDICAL:THERE WILL BE NO SAMPLE RETURNED. A FOLLOW-UP INVESTIGATION WILL BE SENT WHEN COMPLETED.
HUMIDIFYING DEVICE TELEFLEX MEDICAL:THE EVENT IS REPORTED AS: COMPLAINT INDICATES THAT AN ALLEGED DEATH OCCURRED DUE TO A MUCUS PLUG. CO
HUMIRA PEN ABBOTT LABS:HUMIRA 40 MG PEN MAL-FUNCTIONED. I TAKE A SHOT EVERY WEEK. ONE PEN MALFUNCTIONED LAST WEEK, AND ANOT
HUNSAKER MON-JET VENTILATION TUBE MEDTRONIC XOMED, INC.:PATIENT WAS EXTUBATED AND PORTION OF THE TUBE PEELED OFF OF THE VENTILATION TUBE.NOTHING LEFT IN PAT
HYDRELLE COAPT SYSTEMS INC:I INJECTED HYDRELLE 1CC TO HER LIPS SUCCESSFULLY IN 2009. ABOUT A MONTH LATER, SHE DEVELOPED GENERAL
HYDRELLE, 1 CC COAPT SYSTEMS INC:PT HAD HYDRELLE DERMAL FILLER INJECTED TO HER LIPS BY ME IN 2009. FOUR DAYS LATER, SHE DEVELOPED A L
HYDROCEPHALUS VALVE SOPHYSA:RESULTS OF ANALYSIS WILL BE DEVELOPED IN A FOLLOW-UP REPORT.
HYDROPHILIC GUIDEWIRE BOSTON SCIENTIFIC:DURING AN ANGIOGRAM, A PIECE OF THE HYDROPHILIC GUIDEWIRE BROKE OFF INSIDE OF THE PATIENT'S LEG ANTE
HYPERBARIC CHAMBER SECHRIST INDUSTRIES, INC.:THE FOLLOWING WAS PROVIDED DESCRIPTION OF EVENTS TRANSCRIBED FROM LETTER SENT WITH MEDWATCH FORM. "T
HYPODERMIC NEEDLE BD:THE NEEDLE WAS BENT TO DELIVER LOCALLY AT AN ANGLE INSIDE AN INCISION. UPON TAKING THE NEEDLE OFF TH
HYPOTHERMIA VEST GAYMAR INDUSTRIES:PATIENT HAD A PROLONGED CARDIAC ARREST WITH CPR. FOLLOWING HYPOTHERMIA PROTOCOL, THE APPARATUS WAS
HYSTEROSCOPY KARL STORZ:DURING HYSTEROSCOPY, PORCELAIN TIP OF HYSTEROSCOPY SHEATH FRACTURED INSIDE PT'S UTERUS. FRAGMENTS RE
HYSTEROSCOPY SHEATH KARL STORZ:DURING HYSTEROSCOPY, PORCELAIN TIP OF HYSTEROSCOPY SHEATH FRACTURED INSIDE PT'S UTERUS. FRAGMENTS RE
I-STAT1 SYSTEM MANUAL ABBOTT POINT OF CARE:ADD'L CATALOG# 06F20-01.
IABP ARROW CARDIAC DIVISION:ARROW INTRAAORTIC BALLOON PUMP CATHETER FAILED TO DEPLOY. (B) (4) LOT# MF9120678. EQUIPMENT WAS REPL
IABP CARDIAC CARE:ARROW INTRA-AORTIC BALLOON PUMP FAILED TO CLEAR INSERTION SHEATH RESULTING IN FAILURE TO DEPLOY. NEW
IABP CARDIAC CARE DIVISION:ARROW 40CC IABP UNABLE TO BE INSERTED THROUGH IABP SHEATH BY DR. IABP REMOVED BY DR AND NEW IABP INS
IABP - BALLOON CATH BALLOON 7FR X 40CC F/O DATASCOPE:RUPTURED IABP WHILE IN PLACE. BLOOD NOTED IN IABP LINE. REQUIRED RIGHT FEMORAL CUT DOWN AND REMOVAL
ICD BIOTRONIK SE & CO KG:PER BIOTRONIK PT TRACKING, THIS SYSTEM WAS REMOVED DUE TO INFECTION. A REPLACEMENT LUMAX 540 VR-T, (
ICD BIOTRONIK SE & CO. KG:PER BIOTORNIK PT TRACKING, THIS SYSTEM WAS REMOVED DUE TO A SEPTICEMIA WITH VEGETATION THE SVC COIL.
ICD BIOTRONIK SE & CO. KG.:THE DEVICE WAS EXPLANTED DUE TO INFECTION. THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF
ICD LEAD BIOTRONIK SE & CO. KG:.
ICD LEAD BIOTRONIK SE & CO KG:.
ICD LEAD BIOTRONIK SE & CO. KG:PER BIOTORNIK PT TRACKING, THIS SYSTEM WAS REMOVED DUE TO A SEPTICEMIA WITH VEGETATION THE SVC COIL.
ICD LEAD BIOTRONIK SE & CO. KG,:THIS SYSTEM WAS REMOVED DUE TO INFECTION. LEXOS DR, MDR 1028232-2010-00004. SETROX S 45, MDR 1028232
ICD LEAD BIOTRONIK SE & CO. KG.:PER (B) (6) ADVERSE EVENT REPORT, THIS PT EXPERIENCED A LARGE PERICARDIAL EFFUSION. "DELAYED IMPLANT
ILLUMINATOR, TRIVEX SMITH & NEPHEW:DURING VARICOSE VEIN SURGERY USING THE TRIVEX SYSTEM SURGEON DISCOVERED THAT THE ILLUMINATOR TO THE
IMAGING COIL, CARDIAC, 6 CHANNEL, 3T PHILIPS MEDICAL SYSTEMS:PATIENT WAS GETTING AN MRI SCAN INVOLVING HER PELVIS WHEN PATIENT COMPLAINED OF A BURNING SENSATION
IMMUNOCHEMISTRY ANALYZER ROCHE DIAGNOSTICS:.
IMMUNOCHEMISTRY ANALYZER - CEM ROCHE DIAGNOSTICS CORP.:CUSTOMER RECEIVED AN ERRONEOUS POSITIVE BETA HCG PT RESULT. WHEN CUSTOMER RAN THE SAME SAMPLE AGAIN,
IMMUNOCHEMISTRY ANALYZER - JJE ROCHE DIAGNOSTICS:USER REPORTED AN ONGOING ISSUE WITH DISCREPANT TSH RESULTS SINCE (B) (6) 2009. TOTAL NUMBER OF PATIE
IMMUNOCHEMISTRY ANALYZER -CEM ROCHE DIAGNOSTICS CORP.:AN ADDITIONAL PT INVOLVED IN THIS EVENT.
IMMUNOCHEMISTRY ANALYZER-CEM ROCHE DIAGNOSTICS:THE USER NOTED A DIFFERENCE IN T4 RESULTS FOR A PT SAMPLE TESTED ON THE E601 AND ON THE ARCHITECT. A
IMPACTOR, MANUAL SURGICAL INSTRUMENT MEDACTA INTERNATIONAL, SA:THE IMPACTING RING AND IMPACTION HANDLE WAS ASSEMBLED. PRIOR TO IMPACTION OF THE FINAL IMPLANT, THE
IMPANT, HIP, SCREW, TAPER HOWMEDICA OSTEONICS CORP:PATIENT WAS HAVING LEFT HIP CONVERSION OF PRIOR FRACTURE TO TOTAL HIP ARTHROPLASTY. WHILE PUTTING IN
IMPEDANCE CONTROLLE ENDOMETRIAL ABLATION SYSTEM CYTYC SURGICAL PRODUCTS:PT WAS SCHEDULED TO HAVE HYSTEROSCOPY WITH NOVASURE ABLATION. PT INSISTED TO STILL GO THROUGH THE PR
IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION DISPOSAB NOVACEPT, INC.:PT TO SURGERY FOR ELECTED PROCEDURE OF HYSTEROSCOPY; ENDOMETRIAL NOVASURE ABLATION. DURING ABLATION,
IMPEDEANCE CONTROLLED ENDOMETRIAL ABLATION DISPOSA HOLOGIC, INC.:AFTER COMPLETION OF ABLATION PROCEDURE, THE PHYSICIAN NOTED THE SHEATH TO BE MELTED. THERE WAS NO H
IMPLANT STRYKER BIOTECH:FOLLOW UP INFORMATION WAS RECEIVED ON 01/08/2010 FROM A PREVIOUSLY SUBMITTED MDR (1224732-2009-00056
IMPLANT STRYKER ENDOSCOPY PUERTO RICO:IT WAS REPORTED THAT IN 2009, THE PRIMARY SURGERY WAS PERFORMED FOR BOTH SIDES OF THE MANDIBULAR JOI
IMPLANT STRYKER ORTHOPAEDCIS MAHWAH:IT WAS REPORTED THAT, "PATENT PRESENTED TO THE ER WITH A DISLOCATED HIP AND COULD NOT REDUCE HER IN
IMPLANT STRYKER ORTHOPAEDIC CORK:THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADD
IMPLANT STRYKER ORTHOPAEDIC MAHWAH:IT WAS REPORTED THAT, "REVISION OF DURACON KNEE FOR PAIN. EXPLANT DURACON KNEE. IMPLANTED TRIATHLON
IMPLANT STRYKER ORTHOPAEDICS:IT WAS REPORTED THAT, "CONSTRAINED LINER FAILED. THE BIPOLAR COMPONENT ITSELF CAME ENTIRELY BUT OUT
IMPLANT STRYKER ORTHOPAEDICS LIMERICK:AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER.
IMPLANT STRYKER ORTHOPAEDICS CAEN:A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
IMPLANT STRYKER ORTHOPAEDICS CAEN, BENOIST GIRARD & CIE S.:REVISION SURGERY REQUIRED. RELAXATION OF THE SHAFT. ((B) (6)).
IMPLANT STRYKER ORTHOPAEDICS CORK:IT WAS REPORTED THAT, "SURGEON REMOVED A CERAMIC HEAD AND LINER FROM PT. THE HEAD WAS VERY WORN AND
IMPLANT STRYKER ORTHOPAEDICS CORK STRYKER ORTHOPAEDICS:AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MD
IMPLANT STRYKER ORTHOPAEDICS CORK STRYKR ORTHOPAEDICS:AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MD
IMPLANT STRYKER ORTHOPAEDICS CORK, STRYKER ORTHOPAEDICS:DEVICE DID NOT FUNCTION AS EXPECTED. PT REPORTED THAT "APPROXIMATELY ONE MONTH AGO HE BEGAN TO EXPER
IMPLANT STRYKER ORTHOPAEDICS LIMERICK:IT WAS REPORTED THAT PT HAD REVISION SURGERY DUE TO RHEUMATOID ARTHRITIS.
IMPLANT STRYKER ORTHOPAEDICS LIMERICK, STRYKER ORTHOPAEDIC:AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MD
IMPLANT STRYKER ORTHOPAEDICS MAHWA:AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER.
IMPLANT STRYKER ORTHOPAEDICS MAHWAH:A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
IMPLANT STRYKER ORTHPAEDICS MAHWAH:IT WAS REPORTED THAT: "SURGEON THOUGHT SCREW WAS BACKING OUT. DURING SURGERY SURGEON NOTICED THE POS
IMPLANT STRYKER OSTEOSYNTHESIS FREIBURG:THE PT SUSTAINED FACIAL TRAUMA IN 2008 WHICH RESULTED IN A FRACTURE OF THE LEFT ANGLE OF THE MANDIBL
IMPLANT STRYKER OSTEOSYNTHESIS KIEL:ADD'L INFO HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
IMPLANT STRYKER OSTEOSYNTHESIS KIEL, KIEL OPERATIONS:AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, STRYKER CORP CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVI
IMPLANT STRYKER OSTEOSYNTHESIS SELZACH:ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETE ANY ADDITIONAL I
IMPLANT STRYKER OSTEOSYNTHESIS SELZACH, STRYKER OSTEOSYNTH:AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE M
IMPLANT STRYKER SPINE BORDEAUX:ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL.
IMPLANT STYKER ORTHOPAEDICS MAHWAH:IT WAS REPORTED THAT, "THE ABOVE LISTED IMPLANTS WERE REMOVED DUE TO LOOSENING OF THE ACETABULAR SHE
IMPLANT STYRKER ORTHOPAEDICS:USER RELATED. IT WAS REPORTED THAT LEFT FEMORAL COMPONENT WAS IMPLANTED IN A PT'S RIGHT KNEE.
IMPLANT STYRKER ORTHOPAEDICS MAHWAH:AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS IMPLANTED IN THE PT AND WAS NOT RE
IMPLANT - CAGE - VERTICORE COMPANY:PT UNDERGOING MINIMALLY INVASIVE PLIF L5-S1. IMPLANT BROKE DURING INSTALLATION. ALL PIECES REMOVED.
IMPLANT, BREAST, SAILINE-FILLED ALLERGAN:NOTES FROM THE HISTORY AND PHYSICAL:HEALTHY PATIENT WITH HISTORY OF LEFT BREAST CANCER AND RECONSTRU
IMPLANT, DENTAL, ENDOSSEOUS ORMCO CORPORATION:ON JANUARY 14, 2010, A DOCTOR REPORTED TO SYBRON IMPLANT SOLUTIONS THAT AN 8MM VECTOR SCREW BROKE OF
IMPLANT, ENDOSSEOUS, ROOT-FORM EBI INC.:ON (B) (6) 2009, A DOCTOR REPORTED THAT A PATIENT LOST A DENTAL IMPLANT ABOUT 4 MONTHS AFTER PLACEME
IMPLANT, HIP DEPUY ORTHOPAEDICS, INC.:OR CHARGE NURSE WAS NOTIFIED FROM A DEPUY REPRESENTATIVE, CONCERNING AN INCREASE IN HIP FAILURE RATE
IMPLANT, HIP, ACETABULAR CUP ZIMMER GMBH:NOTES FROM DISCHARGE SUMMARY: "THE PATIENT WAS KNOWN TO HAVE A FAILED LEFT TOTAL HIP ARTHROPLASTY, A
IMPLANT, HIP, FEMORAL HEAD SMITH & NEPHEW, INC.:PATIENT HAD A TOTAL HIP ARTHROPLASTY PERFORMED ON HER LEFT HIP. POSTOPERATIVELY, SHE WAS WELL UNTIL
IMPLANT, HIP, SHELL WRIGHT MEDICAL TECHNOLOGY, INC.:SCREW FIXATION WAS EXTREMELY DIFFICULT AND THEY DID NOT SEAT WELL. THE BIOFOAM CUP WAS NOT MACHINED
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY OBTECH MEDICAL SARL_:INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
IMPLANT, INTRAGASTRIC FOR MORBID OBESITYV OBTECH MEDICAL SARL_:(B) (4). (B) (4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
IMPLANT, ORTHOPEDIC, BOW PLATE WRIGHT MEDICAL TECHNOLOGY:PATIENT HAVING HARDWARE REMOVED FROM FOOT DUE TO COMPLIANTS OF IRRITATION AND PAIN. THE HARDWARE WAS
IMPLANT, ORTHOPEDIC, HIP, ACETABULAR LINER BIOMET:PATIENT NOTED LEFT DEEP MEDIAL GROIN PAIN SIX MONTHS AGO. ONE MONTH AGO, RADIOGRAPHS SHOWED THAT THE
IMPLANT, ORTHOPEDIC, TOE MEMOMETAL INC. USA.:PATIENT HAD TOE IMPLANT PUT IN 4 MONTHS AGO. SHE WAS ORIGINALLY TREATED FOR A HAMMER TOE. THE IMPLAN
IMPLANT, PENILE PROSTHESIS COLOPLAST CORPORATION:NOTES FROM HISTORY AND PHYSICAL: "PATIENT WITH HISTORY OF INFLATABLE PENILE PROSTHESIS PLACEMENT FOU
IMPLANT, SPINAL SYNTHES USA:WHILE EXPANDING THE CAGE, THE CAGE SEPARATED INTO 2 PIECES.
IMPLANTAABLE CARDIOVERTER DEFIBRILLATOR ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION:ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. REVIEW OF QUALITY RECORDS.
IMPLANTABLE CARDIAC MONITOR ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION:ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. REVIEW OF QUALITY RECORDS.
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR GUIDANT CORPORATION:THE PATIENT'S MEDICATION REGIMEN WAS ADJUSTED. A NON-INVASIVE PROGRAMMED SIMULATION WAS PERFORMED WI
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR GUIDANT CRM CLONMEL IRELAND:THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS EVENT WILL BE UPDATED AND RESUBMITTED UPON
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SORIN CRM S.A.S.:AFTER 34 MONTHS OF IMPLANTATION, THIS ICD WAS EXPLANTED FOR AN INFECTION.
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION:THE DEVICE WAS REPORTED TO BE AT ERI WITH NO TELEMETRY. THE DEVICE WAS EXPLANTED.
IMPLANTABLE CARDIVERTER DEFIBRILLATOR GUIDANT CRM CLONMEL IRELAND:THE LOCAL BOSTON SCIENTIFIC CRM FIELD REPRESENTATIVE IS ATTEMPTING TO RETRIEVE THE DEVICE FOR RETURN
IMPLANTABLE CHF GENERATOR GUIDANT CRM:IT IS UNKNOWN IF THIS DEVICE WAS EXPLANTED OR BURIED WITH THE PATIENT. AS A RESULT, BOSTON SCIENTIFI
IMPLANTABLE CHF GENERATOR GUIDANT CRM CLONMEL IRELAND:ANALYSIS IS ONGOING.
IMPLANTABLE CHF PULSE GENERATOR GUIDANT CRM CLONMEL IRELAND:SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
IMPLANTABLE CLIP (FZP) NITI MEDICAL SOLUTIONS LTD.:THIS REPORT IS SUBMITTED ON BEHALF OF THE MANUFACTURER ((B) (4)) AND THE IMPORTER ((B) (4)). THE DEV
IMPLANTABLE CLIP (FZP) NITI SURGICAL SOLUTIONS LTD.:THIS REPORT IS SUBMITTED ON BEHALF OF THE MANUFACTURER AND THE IMPORTER. NO CORRECTIVE OR REMEDIAL A
IMPLANTABLE CLIP (FZP) NITI SURGICAL SOLUTIONS, LTD.:A PT WITH RECTAL CANCER UNDERWENT LAR PROCEDURE ON (B) (6) 2010. END TO END ANASTOMOSIS WAS PERFORME
IMPLANTABLE HYDRAULIC FECAL CONTINENCE DEVICE AMERICAN MEDICAL SYSTEMS, INC.:ON (B) (6) 2009, AN ACTION DEVICE WAS IMPLANTED. ON (B) (6) 2009, THE ENTIRE DEVICE WAS REMOVED DUE
IMPLANTABLE HYDRAULIC FECAL INCONT DEVICE AMERICAN MEDICAL SYSTEMS, INC.:(B) (4).
IMPLANTABLE LEAD CPI - DEL CARIBE:BOSTON SCIENTIFIC (BSC) CRM RECEIVED INFO THAT A DEATH CERTIFICATE WAS SENT TO BSC BY THE PT'S WIFE
IMPLANTABLE LEAD CPI PLANT - ST. PAUL:BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS PACING SYSTEM EXPERIENCED A FA
IMPLANTABLE LOOP RECORDER MEDTRONIC MED REL, INC.:THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS
IMPLANTABLE PACEMAKER PULSE GENERATOR ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION:.
IMPLANTABLE PACEMAKER/CARDIO/DEFIB MEDTRONIC MED REL, INC.:THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATE
IMPLANTABLE PACEMAKER/CARDIO/DEFIB MEDTRONIC S.A.:THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITION
IMPLANTABLE PACEMAKER/CARDIO/DEFIB MEDTRONIC, INC.:A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING MULTIPLE ICDS. MULTIPLE PATIENTS
IMPLANTABLE PACING LEAD MEDTRONIC OF CANADA LTD.:THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITION
IMPLANTABLE PACING LEAD MEDTRONIC PUERTO RICO, INC.:DURING A REGULAR CHECK, LEAD WARNING WAS CONFIRMED, DUE TO HIGH VENTRICULAR IMPEDANCE AND PACING FAI
IMPLANTABLE PACING LEAD MEDTRONIC, INC.:IT WAS REPORTED THE LEAD WAS OVERSENSING CAUSING INAPPROPRIATE SHOCKS AND THERE WAS INCREASED NOISE.
IMPLANTABLE PULSE GENERATOR ADVANCED NEUROMODULATION SYSTEMS:THE PT RECEIVED HIS IPG ON (B) (6) 2007. IT WAS REPORTED THAT THE PT WAS COMPLAINING OF A SHOCKING S
IMPLANTABLE PULSE GENERATOR ADVANCED NEUROMODULATION SYSTEMS, INC:IT WAS REPORTED THAT THE PT'S IPG POCKET WAS INFECTED. THE PT WAS PLACED ON ORAL ANTIBIOTICS AND IS
IMPLANTABLE PULSE GENERATOR ADVANCED NEUROMODULATION SYSTEMS, INC.:EVALUATION: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY
IMPLANTABLE PULSE GENERATOR GUIDANT CLONMEL IRELAND:UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE PASSED ALL MANUAL ELECTRICA
IMPLANTABLE PULSE GENERATOR GUIDANT CRM CLONMEL IRELAND:BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THIS PACING SYSTEM WAS IMPLANTED ON FEB 3, 2010. DURING THE
IMPLANTABLE PULSE GENERATOR HISTORICAL CPI - ST. PAUL:BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW-UP VISIT, A DEVICE BATTERY STATUS CO
IMPLANTABLE PULSE GENERATOR MEDTRONIC MED REL, INC.:THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS
IMPLANTABLE PULSE GENERATOR MEDTRONIC OF CANADA LTD.:IT WAS REPORTED THE DEVICE HAD NO OUTPUT. IT WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HA
IMPLANTABLE PULSE GENERATOR MEDTRONIC PUERTO RICO, INC.:IT WAS REPORTED THAT PRIOR TO IMPLANT THE DEVICE COULD NOT BE PROGRAMMED, AND THAT A SAFETY MECHANIS
IMPLANTABLE PULSE GENERATOR MEDTRONIC S.A.:THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITION
IMPLANTABLE PULSE GENERATOR MEDTRONIC, INC.:THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITION
IMPLANTABLE PULSE GENERATOR VITATRON MEDICAL B.V.:THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A
IMPLANTABLE PULSE GENERATOR (IPG) ADVANCED NEUROMODULATION SYSTEMS, INC.:THE PT REPORTED THAT THEIR IPG TURNED ITSELF OFF 3 TIMES IN 8 DAYS. EACH TIME THE IPG TURNED ITSELF
IMPLANTABLE SPINAL CORD STIMULATOR ADVANCED NEUROMODULATION SYSTEMS:THE PT RECEIVED HER SCS SYSTEM CONSISTING OF A RECEIVER AND 2 LEADS. IT WAS REPORTED THAT THE PT EXP
IMPLANTABLE TACHY LEAD MEDTRONIC PUERTO RICO, INC.:THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITION
IMPLANTABLE TACHY LEAD MEDTRONIC, B.V.:THE RIGHT VENTRICULAR AND ATRIAL LEADS WERE BOTH RETURNED TO THE MANUFACTURER, ANALYZED AND SUBSEQUE
IMPLANTABLE TACHY LEAD MEDTRONIC, INC.:IT WAS REPORTED THE DEVICE SYSTEM WAS EXPLANTED DUE TO PERSISTENT BACTEREMIA ON (B) (6) 2009. THE PA
IMPLANTED STRYKER ORTHOPAEDICS MAHWAH:IT WAS REPORTED THAT "THE ARTHROPLASTY WAS REVISED DUE TO LOOSENING, STIFFNESS, AND A PATELLAR INSTA
IMPLANTED LONG TERM INTRAVASCULAR CATHETER C. R. BARD INC.(BASD):PT DEVELOPED A LINE INFECTION.
IMPLANTED SCS FOR PAIN RELIEF, ANCHOR ADVANCED NEUROMODULATION SYSTEMS, INC.:DEVICE 5 OF 6. (REFER TO MFR'S REPORT NUMBER, 1627487-2010-0014 FOR DEVICE 1, 1627487-2010-0015 FOR
IMPLANTED SPINAL CORD STIMULATOR ADVANCED NEUROMODULATION SYSTEMS:EVALUATION: DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND
IMPLANTED, FECAL, INCONTINENCE CONVATEC:FLEXISEAL WAS BEING USED ON A PT BEING TREATED FOR CIRRHOSIS AND LIVER FAILURE. THE PT WAS TURNED AN
IMPLANTIBLE HYDRAULIC FECAL CONTINENCE DEVICE AMERICAN MED SYSTEMS, INC.:IN 2004, AN ACTICON DEVICE WAS IMPLANTED. IN 2008, THE PUMP WAS REVISED. IN 2009, THE PUMP AND BALLO
IMPLANTIBLE HYDRAULIC FECAL CONTINENCE DEVICE AMERICAN MEDICAL SYSTEMS, INC.:IMPLANTED ON (B) (6) 2007. ON (B) (6) 2009, THE ENTIRE DEVICE WAS REPLACED DUE TO "TISSUE ATROPHY UN
IMPLANTS, HIP WRIGHT MEDICAL TECHNOLOGY, INC.:PATIENT HAS EARLY LOOSENING OF HIS RIGHT HIP FEMORAL COMPONENT CONSISTENT WITH OSTEOLYSIS FROM METAL
IN-LINE SUCTION SYSTEM BALLARD MEDICAL PRODUCTS:SUCTION CATHETER, WITHIN PROTECTIVE SHEATH OF BALLARD TRACHEOSTOMY IN-LINE CATHETER, SEPARATED FROM
INCISOR PLUS SMITH AND NEPHEW:DURING SHOULDER ARTHROSCOPY, PHYSICIAN WAS USING A REPROCESSED INCISOR PLUS. FRAGMENTS OF METAL WERE
INCLINATION SET / HSD AARAU SWITZERLAND MANUFACTURING SITE:IT WAS REPORTED THAT THE SCREW OF THE INCLINATION SET FRACTURED REQUIRING A REVISION SURGERY TO CORR
INCLINATION SET / HSD SMITH-NEPHEW INC.:IT WAS REPORTED THAT SURGERY TIME WAS EXTENDED, DUE TO AN INCLINATION SCREW BREAKING.
INCOMPASS ZIMMER SPINE:IN 2009, A MALE PATIENT UNDERWENT TLIF REVISION SURGERY AT L5-S1 DUE TO LACK OF FUSION. THE ORIGINAL
INDICATOR, BIOLOGICAL (FRC) ADVANCED STERILIZATION PRODUCTS:NI
INFANT HEEL WARMER TYCO HEALTHCARE GROUP LP:HEEL WARMER PLACED ON PT'S RIGHT FOOT TO PERFORM METABOLIC SCREENING TEST. ASSESSED HEEL WARMER ON P
INFANT NASAL CANNULAE COOPERSURGICAL:INCA INFANT NASAL CANNULAE FOR CPAP IS IMPROPERLY MOLDED. FLASHING FROM THE MOLD PROCESS OCCLUDED TH
INFANT RADIANT WARMER DRAEGER MEDICAL SYSTEMS, INC. (PNC):THE BIOMED STATED THAT SHE REPLACED THE QUARTZ HEATING ELEMENT WHILE THE WARMER WAS LOCATED IN THE N
INFANT RADIENT WARMER DRAEGER MEDICAL, INC.:THE PT WAS ON A RADIANT WARMER. THE RN AT THE PT'S BEDSIDE WAS PREPARING FOR A PORTABLE XRAY TEST.
INFANT RESP CIRC HTD 4 FT CAREFUSION:SAMPLES RECEIVED FOR EVAL WERE VISUALLY INSPECTED AND LEAK TESTED. BOTH THE VISUAL INSPECTION AND LE
INFANT WARMER DRAEGER MEDICAL, INC.:POST DELIVERY, BABY BROUGHT TO NURSERY AND PLACED ON WARMER, WHICH WAS SET AT 37.4 C. TEMP PROBE PLA
INFANT WARMER GE HEALTHCARE:RECEIVED PATIENT AND UPON FIRST ASSESSMENT ONE HOUR LATER FOUND LIGHT ON OMNI BED TO BE UNDER THE RA
INFIX ZIMMER SPINE:EVALUATION IS PENDING UPON COMPLETED INVESTIGATION OF THE PRODUCT AND REQUESTS HAVE BEEN MADE FOR RE
INFLATABLE BONE TAMP MEDTRONIC SPINE LLC.:DEVICE NOT RETURNED, FOLLOW UP WITH COMPANY REP.
INFLUENZA A&B CLIA WAIVED 22 TEST KIT INVERNESS MEDICAL:WHEN COLLECTION A NASOPHARYNGEAL SAMPLE FOR THE BINAXNOW INFLUENZA A&B TEST KIT, THE PLASTIC SHAFT O
INFRARED LAMP ANODYNE THERAPY, LLC:COMPANY HAS BEEN NOTIFIED THAT THE HOSPITAL HAS EXPERIENCED AN ADVERSE EVENT WHILE USING THIS ANODYN
INFRARENAL PROXIMAL EXTENSION ENDOLOGIX, INC.:ADDITIONAL DEVICE INFO: MODEL NO.: 28-28-75L, LOT NO.: W09-3328-008, EXPIRATION DATE: 12/01/2012. RE
INFUSE BONE GRAFT MEDTRONIC SOFAMOR DANEK USA, INC.:A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE
INFUSE-A-PORT BARD:PT HAD A PORT REMOVED ON (B) (6) 2009. RETURNED ON (B) (6) 2009 TO HAVE A PLASTIC CONNECTOR FROM THE
INFUSILN INFUSION PUMP DISETRONIC MEDICAL SYSTEMS:THE PT REPORTED EXPERIENCING ERRATIC BLOOD GLUCOSE OF 350-400 MG/DL LEVELS SINCE (B) (6) OR (B) (6)
INFUSIOIN PUMP MEDTRONIC PUERTO RICO OPERATIONS MED-REL:IT WAS REPORTED THAT THE CUSTOMER WAS IN THE HOSPITAL FOR AN INSULIN ADJUSTMENT. TROUBLESHOOTING WAS
INFUSION PUMP MEDTRONIC PUERTO RICO OPERATIONS MED-REL:CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO
INFUSION PORT MEDCOMP:AN INVESTIGATION HAS BEEN INITIATED. A REVIEW OF THE MFG RECORDS INDICATED THAT ALL DEVICE SPECS AND
INFUSION PORT SMITHS MEDICAL:PATIENT HAD PORT PLACED IN 2008 FOR TREATMENT OF CANCER. RETURNED IN 2009 TO HAVE THE PORT CHECKED B
INFUSION PUMP ALARIS: CAREFUSION 303, INC.:INFUSION PUMP STOPPED WORKING AND DISPLAYED "MALFUNCTION."
INFUSION PUMP B BRAUN:FACILITY BECAME AWARE OF A TREND IN "SMART PUMP" ERRORS OVER THE LAST 2-3 WEEKS. SIX (6) FOR THE MOI
INFUSION PUMP B. BRAUN MEDICAL, INC.:A PATIENT WAS SEDATED AND ON A VENTILATOR WHILE RECEIVING A CONTINUOUS IV INFUSION OF NOREPINEPHRINE
INFUSION PUMP BREG INC.:PT HAD 2 SHOULDER SURGERIES. FIRST WAS ON (B) (6) 2003 FOR THE RIGHT SHOULDER. A PAIN CARE 3000 WAS
INFUSION PUMP BREG, INC.:PT HAD SHOULDER SURGERY ON (B) (6) 2007. A PAIN CARE 3200 WAS USED DURING THE SURGERY. PT NOW ALLEGE
INFUSION PUMP CAREFUSION 303, INC.:PATIENT ON ALARIS PUMP; INFUSING. BEGAN TO BEEP WITH SYSTEM MALFUNCTION ERROR MESSAGE ON SCREEN. PUM
INFUSION PUMP CAREFUSION HEALTHCARE CARDINAL HEALTH:THE FIRST INCIDENT INVOLVED A NON-DELIVERY OF NEOSYNEPHRINE. THE NEOSYNEPHRINE WAS PROGRAMMED TO AD
INFUSION PUMP CAREFUSION-ALARIS:PATIENT'S PUMP WAS FOUND TO BE BUZZING AND STATING INSTRUMENT MALFUNCTION. UNPLUGGED PUMP AND REMOVE
INFUSION PUMP MEDTRONIC MINIMED:IT WAS STATED THAT THE CUSTOMER PASSED AWAY DUE TO DIABETES COMPLICATIONS. IT WAS STATED THAT THE CU
INFUSION PUMP MEDTRONIC PUERTO RICO OPERATIONS CO, MED REL:CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVI
INFUSION PUMP MEDTRONIC PUERTO RICO OPERATIONS CO. MED-REL:IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPOGLYCEMIA. TROUBLESHOOTING WAS PERFORME
INFUSION PUMP MEDTRONIC PUERTO RICO OPERATIONS MED -REL:IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. IT WAS NOT KNOWN IF
INFUSION PUMP MEDTRONIC PUERTO RICO OPERATIONS MED-REL:CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO
INFUSION PUMP MEDTRONIC PUETO RICO OPERATIONS MED-REL:THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO AN INFECTION AT THE INFUSION SITE. THE CUSTOMER
INFUSION PUMP SMITHS MEDICAL ASD, INC.:SYRINGE PUMP ALARMED "MOTOR RATE ERROR" AFTER OVER HALF OF THE INFUSION OF CLINDAMYCIN HAD GONE IN T
INFUSION PUMP STRYKER INSTRUMENTS KALAMAZOO:IN 2009, STRYKER RECEIVED A LAWSUIT ALLEGING THAT A PT WAS PRESCRIBED A STRYKER PAINPUMP2 FOLLOWING
INFUSION PUMP STRYKER INSTRUMENTS PUERTO RICO:THE PUMP WAS NOT RETURNED TO THE MFR, IF ADDITIONAL INFO IS RECEIVED, A FOLLOW UP REPORT CAN BE SUBM
INFUSION PUMP, ABULATORY SMITH MEDICAL:PATIENT ADMITTED WITH CADD (COMPUTERIZED AMBULATORY DELIVERY DEVICE) PUMP IN PLACE FOR FLOLAN INFUSI
INFUSION SET ALARIS/CARDINAL HEALTH:I.V. PUMP ALARMING "AIR IN LINE", ALARM WOULD NOT CLEAR. TUBING REMOVED FROM PUMP CHAMBER TO CLEAR A
INFUSION SYSTEM PUMP SYSTEM B. BRAUN:RN REPORTS THE WHITE SHARP SPIKING TIP ON THE B. BRAUN Y SITE BLOOD TUBING CAME DISCONNECTED FROM TH
INFUSION TUBING B-BRAUN:THE PATIENT WAS RECEIVING CHEMOTHERAPY, AVASTIN, VIA B-BRAUN ULTRASITE IV TUBING. THE PATIENT WAS H
INFUSOR, PRESSURE, FOR IV BAGS MERIT MEDICAL SYSTEMS, INC.:.
INHIBIN A ENZYME-LINKED IMMUNOSORBENT (ELISA) BECKMAN COULTER INC.:A CUSTOMER REPORTED TO BECKMAN COULTER INC., (BCI) THAT THREE PATIENT SAMPLES GAVE HIGHER THAN EXPEC
INJECTABLE GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/ SANOFI-:INITIAL AND ADDITIONAL INFORMATION RECEIVED FROM A CONSUMER IN 2009. THIS CASE IS 1 OF 2: A FEMALE P
INJECTABLE IMPLANT BIOFORM MEDICAL, INC.:A PATIENT (PHYSICIAN) INJECTED HIMSELF IN THE CHEEKS WITH RADIESSE DERMAL FILLER ON (B) (6) 2009. ON
INJECTION IMPLANT BIOFORM MEDICAL, INC.:PT WAS DIAGNOSED WITH POSSIBLE GUILLAIN-BARRE SYNDROME IN THE EMERGENCY ROOM AND ADMITTED FOR OBSERV
INJECTION NEEDLE COOK MEDICAL:ATTEMPTED TO USE TWO DIFFERENT SCLEROTHERAPY NEEDLES BUT NEEDLES ADVANCED THROUGH SIDE OF SHEATH. NE
INNER SLEEVE MEDTRONIC SOFAMOR DANEK INSTRUMENT:THE PRODUCT WAS NOT RETURNED FOR EVAL. WITH THE AVAILABLE INFO, A CAUSE OR CONTRIBUTING FACTOR CANNO
INNOVA 4100 IQ GE HEALTHCARE:THERE IS A SERIOUS DESIGN FLAW WITH THE GE INNOVA 4100 IQ EQUIPMENT, ALLOWING THE PROPYLENE GLYCOL F
INQWIRE MERIT MED:A STRAIGHT GUIDE WIRE WAS LOADED IN THE COMPANY PACKAGE INCORRECTLY. THE STRAIGHT GUIDE WIRE CAME OU
INSERT / JDH SMITH & NEPHEW ORTHOPAEDICS:REVISION SURGERY WAS REPORTED DUE TO WEAR.
INSERT / JDH SMITH & NEPHEW ORTHOPAEDICS AG:REVISION SURGERY WAS REPORTED DUE TO WEAR.
INSERT / JWH BROOKS MANUFACTURING SITE:IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN, SWELLING, A POSSIBLE LOOSENING. IT
INSERT / JWH SMITH & NEPHEW, INC., ORTHOPAEDIC DIVISION:IT HAS BEEN REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISASSOCIATION. THE IMPLANT DATE I
INSERT METASUL CSF 55/28 ZIMMER GMBH:CONCLUSION: THE QUALITY RECORDS INDICATE THAT ALL THE SPECIFIED CHARACTERISTICS (MATERIAL, MEASUREME
INSERT/JWH SMITH & NEPHEW AG, AARAU SWITZERLAND MFG:IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION.
INSERTER MEDTRONIC SOFAMOR DANEK:THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MFR CANNOT DETERMINE THE SUSPECT DEVICE. WE AR
INSERTER, IOL EPSILON EYE CARE PVT., LTD:ATTEMPT WAS MADE TO PLACE THE INITIAL TORIC INTRAOCULAR LENS IN THE CAPSULAR BED. THIS LENS WAS A M
INSTRUMENT STRYKER ENDOSCOPY PUERTO RICO:INJURY. THE DOCTOR PERFORMED AN ANKLE ARTHROSCOPY USING A 2.5 MM AGGRESSIVE PLUS CUTTER AND A 3.0 MM
INSTRUMENT STRYKER ORTHOPAEDICS:REVISION SURGERY REQUIRED. IT WAS REPORTED "THE 1.0 RESECTION GUIDE WAS NOT REMOVED DURING SURGERY.
INSTRUMENT STRYKER ORTHOPAEDICS CAEN:A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
INSTRUMENT STRYKER ORTHOPAEDICS MAHWAH:IT WAS REPORTED THAT, "WHEN THE SURGEON INSERTING THE NRG INSERT TRIAL BY USING A HAMMER, IT CRACKED
INSTRUMENT STRYKER OSTEOSYNTHESIS FREIBURG:AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE M
INSTRUMENT STRYKER OSTEOSYNTHESIS KIEL:ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE SUBMITTED ON A SUPPLEMENTAL REPOR
INSTRUMENT STRYKER OSTEOSYNTHESIS KIEL, KIEL OPERATIONS:AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE M
INSTRUMENT STRYKER SPINE BORDEAUX:ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL.
INSTRUMENT / NXT SMITH & NEPHEW ORTHOPAEDICS LTD.:IT WAS REPORTED THAT SURGICAL TIME WAS EXTENDED BY 1 HOUR DUE TO BREAKAGE OF AN INSTRUMENT DURING DE
INSTRUMENT, 8MM CAUTERY INTUITIVE SURGICAL:DURING A ROBOTIC CASE, THE DOCTOR WAS CLEANING THE PERMANENT CAUTERY HOOK WITH THE MARYLAND INSTRUME
INSTRUMENT, LAPAROSCOPIC, DISSECTOR COVIDIEN UNITED STATES SURGICAL CORPORATION:ONE OF THE JAWS OF THE ROTICULATING DISSECTOR BROKE AND HAD TO BE RETRIEVED FROM THE PATIENT.
INSTRUMENT, MANUAL, ORTHOPAEDIC, SURGICAL DEPUY SPINE, INC.:THE INFECTION WHICH OCCURRED FOUR MONTHS AFTER THE ORIGINAL SURGERY WAS NOT ATTRIBUTED TO THE IMPLAN
INSTRUMENT, MANUAL, SURGICAL ARTHREX, INC:MULTI-FIRE SCORPION DID NOT FIRE CORRECTLY. WHEN THE INSTRUMENT WAS REMOVED, OBSERVED TIP WAS MISSIN
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE ARTHREX, INC.:FOLLOW UP WITH THE REPORTER PROVIDED ADDITIONAL INFORMATION THAT DURING A POST-OP OFFICE VISIT AN X-
INSTRUMENT, STEREOTAXIC CONMED LINVATEC:TO DATE, CONMED LINVATEC HAS NOT RECEIVED THIS UNIT FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT
INSTRUMENT, SURG, ORTHOPEDIC, PNEUMATIC CONMED LINVATEC:OUR (B) (4) DISTRIBUTOR REPORTED THAT DURING RECEIVING AND INSPECTION OF THIS DEVICE, THEY FOUND THE
INSTRUMENT, SURGICAL, BONE HARVESTER TRINITY ORTHOPEDICS, LLC:OR TECH ON ADVICE OF SURGEON OPENED A BONE GRAFT HARVESTER ONTO THE STERILE FIELD. THIS PRODUCT WAS
INSTRUMENT, ULTRASONIC SURGICAL ETHICON ENDO-SURGERY, LLC.:IT WAS REPORTED THAT DURING AN OPEN BREAST BIOPSY USING THE FOCUS, AFTER COMPLETING THE CASE, NOT
INSTRUMENT, VESSEL SEALING COVIDIEN-VALLEYLAB:THE LIGASURE HANDPIECE DID NOT WORK, IT ACTED LIKE IT HAD NO POWER. A SECOND HANDPIECE WAS OPENED A
INSTRUMENT, VESSEL SEALING VALLEYLAB:PATIENT UNDERGOING TOTAL VAGINAL HYSTERECTOMY. DURING THE PROCEDURE THE HANDPIECE JAW WOULD NOT OPE
INSTRUMENTATION MEDTRONIC SOFAMOR DANEK USA, INC.:IT WAS REPORTED THAT A PEDIATRIC PT UNDERWENT SIMULTANEOUS ANTERIOR AND POSTERIOR VERTEBRAL RESECTIO
INSTRUMENTS, SURGICAL, CARDIOVASCULAR QUEST MEDICAL, INC.:THE END OF THE AORTIC PUNCH DID NOT MAKE A HOLE IN THE AORTA. NO HARM DONE TO THE PATIENT.
INSUFFLATOR, CO2 KARL STORZ ENDOSCOPY-AMERICA, INC.:PATIENT WAS IN CVOR FOR ROBOT ASSISTED MITRAL VALVE REPAIR/REPLACEMENT. CASE ENDED NORMALLY WITH NO
INSUILN INFUSION PUMP DISETRONIC MEDICAL SYSTEMS:ON (B) (6) 2010, THE PT REPORTED SHE CONTINUES TO SEE AIR BUBBLES IN THE INSULIN CARTRIDGE OF HER IN
INSULIN PUMP SMITHS MEDICAL MD (FORMERLY DELTEC, INC):(B) (4). THE DEVICE IS CURRENTLY BEING EVALUATED; THE MFR WILL FILE A F/U REPORT DETAILING THE RESUL
INSULIN DELIVERY DEVICE NOVO NORDISK A/S, MEDICAL SYSTEMS:A GAP APPEARED BETWEEN THE PLUNGER AND THE BUNG [DEVICE FAILURE]. HYPOGLYCAEMIA RESULTING IN HOSPITA
INSULIN DELIVERY DEVICE NOVO NORDISK A/S,MEDICAL SYSTEMS:MECHANICAL DEFECT [DEVICE MALFUNCTION]. SEMI-COMA [DEPRESSED LEVEL OF CONSCIOUSNESS]. CASE DESCRIPTI
INSULIN INFUSION PUMP ANIMAS CORP.:THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE
INSULIN INFUSION PUMP ANIMAS CORPORATION:IT WAS REPORTED THAT THE PUMP WAS REBOOTING (RESETTING ITSELF WITHOUT INTERVENTION).
INSULIN INFUSION PUMP DISETRONIC MEDICAL SYSTEMS:IN 2009, THE PT REPORTED THAT ABOUT 1 WEEK AGO SHE NOTICED THE DOWN BUTTON ON HER INSULIN INFUSION D
INSULIN INFUSION PUMP DISETRONIC MEDICAL SYSTEMS, INC.:THE PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF 250-400 MG/DL WHILE USING THE INFUSION DEVICE
INSULIN INFUSION PUMP DISETRONIC MEDICAL SYSTEMS.:THE PT'S FATHER REPORTED, THE PT'S BLOOD GLUCOSE MEASURED 180 MG/DL ON (B) (6) 2010 AT 10:10 PM AND
INSULIN INFUSION PUMP ADAPTER DISETRONIC MEDICAL SYSTEMS:IN 2009, PT REPORTED SHE HAS BEEN HAVING SOME HIGHER THAN NORMAL READINGS FOR THE PAST 2 WEEKS. SHE
INSULIN INFUSION PUMP CARTRIDGE DISETRONIC MEDICAL SYSTEMS:NO PRODUCT WILL BE RETURNED FOR EVALUATION.
INSULIN INFUSION PUMP CARTRIDGE DISETRONIC MEDICAL SYSTEMS, INC.:NO PRODUCT WILL BE RETURNED FOR EVAL.
INSULIN INFUSION SET DISETRONIC MEDICAL SYSTEMS:THE PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF UP TO 550 MG/DL AND E4 (OCCLUSION) ERROR
INSULIN INFUSION SET DISETRONIC MEDICAL SYSTEMS,:IN 2009, PATIENT REPORTED SHE AWOKE WITH A BLOOD GLUCOSE READING OF "HI". PATIENT STATED SHE WASN'T
INSULIN INFUSION SET DISETRONIC MEDICAL SYSTEMS, INC.:ON (B) (6) 2010, THE PT REPORTED AN E4 (OCCLUSION) ERROR AND A8 (BOLUS CANCELED) ALARM WERE DISPLAYE
INSULIN PUMP ANIMAS:I BOUGHT AN ANIMAS -A (B) (4) COMPANY- INSULIN PUMP IN (B) (6) 2008. FROM THE BEGINNING, I HAD PROBL
INSULIN PUMP ANIMAS CORPORATION:ANIMAS PING MEDICAL INSULIN PUMP STOPPED WORKING. PATIENT WAS NOT NEAR ANY REPLACEMENT BATTERIES (WA
INSULIN PUMP MEDTRONIC:IN ACCORDANCE WITH (B) (4)), WE ARE NOTIFYING YOU THAT ON DECEMBER 24, 2009, A CUSTOMER CALLED ROCHE
INSULIN PUMP MEDTRONIC MINIMED, INC.:WHILE SLEEPING, THIS INSULIN PUMP DELIVERED A NEAR-FATAL DOSE OF INSULIN. THE PUMP'S HISTORY INDICAT
INSULIN PUMP SMITHS MEDICAL MD (FORMERLY DELTEC, INC):CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE
INSULIN PUMP SMITHS MEDICAL MD (FORMERLY DELTEC, INC.):DEVICE EVALUATION: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. DELIVERY AND ACCURACY TESTS WERE P
INSULIN PUMP SMITHS MEDICAL MD (FORMERLY DETLEC, INC):(B) (4). DEVICE EVALUATION: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. DELIVERY AND ACCURACY TES
INSULIN PUMP CATHETER ANIMAS CORP.:PT HAS A HISTORY OF TYPE 1 DM AND HAS BEEN USING AN ANIMAS IR 2020 PUMP. PT WAS USING A CONTACT-DETA
INSULIN PUMP CATHETER ANIMAS CORPORATION:PATIENT HAS HISTORY OF TYPE 1 DIABETES MELLITUS. PATIENT HAS BEEN USING INSULIN PUMP THERAPY FOR MAN
INSULIN SYRINGE BECTON DICKINSON:NO PRODUCT RETURN IS ANTICIPATED AS COMPLAINT INDICATES THAT THE PRODUCT HAS BEEN DISCARDED. UNABLE
INSULIN SYRINGE BECTON DICKSON:CUSTOMER STATES STOPPER WAS MELTED INTO SYRINGE. WHEN TRIED TO PULL OUT THE WHITE PLUNGER, IT GOT SE
INSULIN SYRINGE U-100 (1 ML 29G X 1/2) BD:PLEASE SEE ATTACHED PACKAGING FOR THE 1/2 ML AND 1 ML SYRINGES. THE PACKAGE IS SO SIMILAR THAT THE I
INSULIN SYRINGE U-100 (1/2 ML 29G X 1/2) BD:PLEASE SEE ATTACHED PACKAGING FOR THE 1/2 ML AND 1 ML SYRINGES. THE PACKAGE IS SO SIMILAR THAT THE I
INSULIN, INFUSION PUMP DISETRONIC MEDICAL SYSTEMS:ON (B) (6) 2010, PATIENT REPORTED THAT FOR THE LAST 3 DAYS, SHE HAS HAD ELEVATED BLOOD GLUCOSE FROM
INSYTE-N AUTOGUARD 246A 0.56IN BD:NURSES REPORTED TODAY (B) (6) 2010, THAT ON (B) (6) 2010, AN IV ATTEMPT WAS DONE AND THE CATHETER SH
INTEGRATED ARTHROSCOPY SYSTEM STRYKER:DURING THE PROCEDURE, THE PHYSICIAN WAS USING THE ABLATION MODE IN THE SUBACROMIAL SPACE; THE DEVICE
INTELLIVUE PATIENT DATABASE SERVER PHILIPS MEDICAL SYSTEMS:THE CUSTOMER WAS REQUESTING INFO DURING A SPECIFIC TIMEFRAME FOR A PT WHO HAD EXPIRED.
INTENSIVE CARE HEMODIALYSIS GAMBRO LUND AB:THE DEVICE INVOLVED WAS NOT INSPECTED BY THE HOSPITAL BIOMEDICAL ENGINEER OR A GAMBRO TECHNICAL SERV
INTENSIVE CARE HEMODIALYSIS GAMBRO LUNDIA AB:A GAMBRO TECHNICAL SERVICE REP INSPECTED THE PRISMAFLEX MACHINE. HE COULD NOT DUPLICATE THE REPORTED
INTER-OP DURASUL ACETABULAR INSERTS/COC ZIMMER GMBH:(B) (4). CONCLUSION: THE INVESTIGATION SHOWS THAT THE CAUSE OF THE WEAR WAS A MISMATCH OF THE MENTIO
INTERBODY DEVICE MEDTRONIC SOFAMOR DANEK USA, INC.:(B) (4). A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL
INTERBODY DEVICE WARSAW ORTHOPEDIC INC.:NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVALUATION.
INTERMATE 100ML/HR BAXTER HEALTHCARE CORP.:INTERMATE SV 100ML/HR BY BAXTER, LOT# 10A057, EXP DATE 12/31/12, PRODUCT ID # 2C1732K. TUBING BROKE
INTERMATE 200ML/HR BAXTER HEALTHCARE CORP.:INTERMATE SV 200 ML/HR BY BAXTER. REF 2 C1734K. LOT# 09N056, EXP DATE 12/31/2012. TUBING BROKE OFF A
INTERMITTENT CATHETER COLOPLAST A/S:DATE OF EVENT: 2009.ACCORDING TO THE INFORMATION RECEIVED, AN END USER USED 2 CATHETERS WHICH FELT
INTERMITTENT CATHETER COLOPLAST MANUFACTURING US, LLC:DATE OF EVENT: 2009.ACCORDING TO THE INFORMATION RECEIVED, AN END USER REPORTED THAT THE TIP OF A CA
INTEROCULAR LENS ALCON RESEARCH. LTD. / HUNTINGTON:THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HI
INTERPOSITIONAL KNEE DEVICE CONFORMIS:A BICOMPARTMENTAL KNEE RESURFACING DEVICE ORDER WAS RECEIVED BY CONFORMIS FOR A PATIENT WITH A INTER
INTERSPINOUS PROCESS SPACER MEDTRONIC SPINE LLC:REPORT SOURCE: SOURCE LITERATURE: PHYSICIAN PRESENTATION TITLED "X-STOP PEEK IPD SYSTEM CASE REVIEWS
INTERSPINOUS PROCESS SPACER MEDTRONIC SPINE LLC.:IT WAS REPORTED THAT A PATIENT UNDERWENT A 2 LEVEL X-STOP PROCEDURE AT LEVELS L3/4 AND L4/5. THE X-S
INTERSPINOUS PROCESS SPACER MEDTRONIC SPINE, LLC.:DEVICE NOT RETURNED, FOLLOWED-UP WITH PT.
INTERSPINOUS PROSCESS SPACER MEDTRONIC SPINE LLC.:REPORT SOURCE. AN ARTICLE TITLED: "PREDICTIVE FACTORS FOR FAILURE AND SURVIVORSHIP ANALYSIS AFTER X
INTERSTIM MEDTRONIC:HAD INTERSTIM REMOVED 2 DAYS AGO DUE TO SEVERE BACK AND LEFT LEG PAIN. IT IS BELIEVED TO HAVE PUT PR
INTERSTIM BLADDER STIMULATOR CABLE MEDTRONIC:DURING SURGERY, THE CABLE ON THE INTERSTIM BLADDER STIMULATOR DISCONNECTED. THIS RESULTED IN THE NEC
INTERVERTEBRAL CAGE PIONEER SURGICAL TECHNOLOGY, INC.:BULLET TIP PIONEER CAGE 14 MM X 26 MM, REF 32-14-26, LOT 039953, EXPIRATION DATE 2013-10 BROKE WHEN
INTERVERTEBRAL DISC EXCISOR SYNTHES (USA) PRODUCTS LLC:ADULT PATIENT WENT TO OR FOR POSTERIOR LUMBAR INTERBODY FUSION AT L4-L5. DURING THE SURGERY, WHILE R
INTRA-AORTIC BALLOON DATASCOPE:AFTER CORONARY PERCUTANEOUS INTERVENTION IN THE CARDIAC CATH LAB ON (B) (6) 2009 AT 11:10 HOURS AN I
INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) ARROW INTL., INC.:IT WAS REPORTED THAT IN 2009, WHILE IN THE CARDIAC CARE UNIT "THE USER DIDN'T PERFORM ZEROING BEFORE
INTRA-AORTIC BALLOON PRODUCTS ARROW INTERNATIONAL INC:(B) (4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
INTRA-AORTIC BALLOON PRODUCTS ARROW INTL., INC.:(B) (4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
INTRA-AORTIC BALLOON PUMP PRODUCTS ARROW INTL., INC.:DEVICE WILL NOT BE RETURNED FOR EVAL.
INTRA-ARTICULAR HYALURONIC ACID GENZYME BIOSURGERY (RIDGEFIELD):RASH ON BOTH LEGS [RASH], ITCHING ON RIGHT FOOT [PRURITIS], TONGUE BEGAN TO SWELL [SWOLLEN TONGUE].
INTRA-ARTICULAR INJECTION FIDIA FARMACEUTICI S.P.A.:THIS FEMALE EXPERIENCED BLOOD CLOT AFTER RECEIVING SERIES OF INJECTIONS WITH HYALURONATE SODIUM. THE
INTRA-ARTICULAR INJECTION FIDIA FARMACEUTICI SPA:THE QUALITY ASSURANCE DEPT AT FIDIA PERFORMED A DEEP EVAL OF THE PRODUCTION AND QUALITY CONTROL DOCU
INTRACARDIAC PATCH OR PLEDGET CORMATRIX CARDIOVASCULAR, INC.:ON 01/13/2010, AN EVENT WAS REPORTED TO CORMATRIX CARDIOVASCULAR INVOLVING A DEATH OF A PEDIATRIC PA
INTRACOLUAR LENS ALCON RESEARCH. LTD. / HUNTINGTON:THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HI
INTRALUMINAL STAPLER ETHICON ENDO-SURGERY:INSTRUMENT USED DURING SURGERY - AFTER FIRING INSTRUMENT, DOCTOR STATED INSTRUMENT "FELL APART". DAT
INTRAOCUAR LENS ALCON RESEARCH. LTD. / HUNTINGTON:THE PRODUCT WAS RETURNED FOR ANALYSIS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A
INTRAOCULAR GAS ALCON - FORT WORTH/ALCON LABORATORIES, INC.:THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED
INTRAOCULAR LENS ABBOTT MEDICAL OPTICS:LENS WAS OPENED, AS TECH STARTED TO FOLD THE LENS, IT APPEARED NOT TO FOLD THE CORRECT WAY. THE LENS
INTRAOCULAR LENS ADVANCED MED OPTICS INC.:SEVERE ENDOPHTHALMITIS DUE TO (B) (6) SALIVARIUM LESS THAN 24 HOURS FOLLOWING EXTRACAPSULAR CATARACT
INTRAOCULAR LENS ALCON:OS - DYSPHOTOPSIA, OD - DYSPHOTOPSIA. I AM A PHYSICIAN WHO IN THIS CASE IS THE PATIENT. YOU MAY HAVE
INTRAOCULAR LENS ALCON LABORATORIES:ATTEMPT WAS MADE TO PLACE THE INITIAL TORIC INTRAOCULAR LENS IN THE CAPSULAR BED. THIS LENS WAS A M
INTRAOCULAR LENS ALCON LABORATORIES IRELAND LTD.:THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HI
INTRAOCULAR LENS ALCON MANUFACTURING, LTD. / HUNTINGTON:A CONSUMER REPORTED HAVING DIFFICULTY READING AT NEAR FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMP
INTRAOCULAR LENS ALCON MANUFACTURING, LTD./ HUNTINGTON:A CONSUMER REPORTED THAT "VISION IS NEVER BETTER THAN 20/50 TO 20/40" AND SHE CAN SEE RINGS AT NIGHT
INTRAOCULAR LENS ALCON MANUFACTURING, LTD./HUNTINGTON:A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE HAD NOTICED
INTRAOCULAR LENS ALCON RESEARCDH, LTD. / HUNTINGTON:THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE
INTRAOCULAR LENS ALCON RESEARCH LTD. / HUNTINGTON:THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HI
INTRAOCULAR LENS ALCON RESEARCH LTD./HUNTINGTON:THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE
INTRAOCULAR LENS ALCON RESEARCH, LTD / HUNTINGTON:THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED
INTRAOCULAR LENS ALCON RESEARCH, LTD / HUNTINGTON.:A NURSE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT WAS EXPERIENCING GLARE
INTRAOCULAR LENS ALCON RESEARCH, LTD.:THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD N
INTRAOCULAR LENS ALCON RESEARCH, LTD. / HUNTINGTON:A SURGEON REPORTED THAT A PT WAS NOT SATISFIED WITH VISUAL ACUITY FOLLOWING INTRAOCULAR LENS (IOL) I
INTRAOCULAR LENS ALCON RESEARCH, LTD./ HUNTINGTON:A TECHNICIAN REPORTED A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (I
INTRAOCULAR LENS ALCON RESEARCH, LTD./HUNTINGTON:IN A LITERATURE REPORT, THE SURGEON REPORTED A PT WITH DECREASED VISUAL ACUITY DUE TO WHITENING OF T
INTRAOCULAR LENS ALCON RESEARCH, LTD/HUNTINGTON:THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HI
INTRAOCULAR LENS ALCON RESEARCH. LTD / HUNTINGTON:THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED
INTRAOCULAR LENS ALCON RESEARCH. LTD. / HUNTINGTON:THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HI
INTRAOCULAR LENS ALCON RESEARCH. LTD. / HUNTINGTON:THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED
INTRAOCULAR LENS ALCON RESEARCH. LTD./ HUNTINGTON:THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED
INTRAOCULAR LENS ALCON RESEARCH. LTD/ HUNTINGTON:THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HI
INTRAOCULAR LENS ALCONRESEARCH LTD./ HUNTINGTON:THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HI
INTRAOCULAR LENS BAUSCH & LOMB:ON (B) (6) 2009, I WENT INTO AN OUTPATIENT SURGERY CENTER FOR CATARACT SURGERY. THEY IMPLANTED A CRY
INTRAOCULAR LENS BAUSCH & LOMB SURGICAL:THE PHYSICIAN REPORTS NOTICING THAT THE CRYSTALENS BECAME DAMAGED AFTER DELIVERY USING THE CRYSTALSE
INTRAOCULAR LENS BAUSCH + LOMB SURGICAL:A PATIENT REPORTS UNDERGOING CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS IN THE RIGHT EYE.
INTRAOCULAR LENS BAUSCH AND LOMB SURGICAL:THE PHYSICIAN REPORTS THAT THE CRYSTALENS HAPTIC TORE DURING DELIVERY USING THE CRYSTALSERT LENS INJ
INTRAOCULAR LENS BOMB & LOMB SURGICAL:THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RE
INTRAOCULAR LENS STAAR SURGICAL CO.:THE RPTR STATED THE SURGEON INSERTED A SILICONE THREE PIECE LENS AND A "C" LIKE TEAR WAS NOTED ON TH
INTRAOCULAR LENS STAAR SURGICAL COMPANY:CONCLUSION: AT THE CONCLUSION OF THE ORIGINAL INVESTIGATION OPENED FOR THE ISSUE OF ICL VAULTING (BO
INTRAOCULAR LENS FOLDERS AND INJECTORS STAAR SURGICAL CO.:(B) (4) (OTHER INSTRUMENT MALFUNCTION): DEVICE EVALUATED BY MFR: NO: LENS, CARTRIDGE, INJECTOR AND F
INTRAOCULAR LENS GUIDE STAAR SURGICAL CO.:THE REPORTER STATED THE SURGEON INSERTED A 20.5 DIOPTER CQ2015A COLLAMER ASPHERIC THREE PIECE LENS A
INTRAOCULAR LENS GUIDE STAAR SURGICAL COMPANY:(B) (4).
INTRAOCULAR LENS IMPLANT OPHTEC/AMO:IOL DISLOCATION OD REQUIRING SURGICAL INTERVENTION ON (B) (6) 2010. (B) (6) CLINIC AMBULATORY SURGER
INTRAVASCULAR AND CAROTID SHUNTS EDWARDS LIFESCIENCES:T3103AS WAS IN SITU AND BURST. IT HAS BEEN REQUESTED MORE INFO TO THE CUSTOMER. COMPLAINT WILL BE UP
INTRAVASCULAR CATHETER BECTON DICKINSON INFUSION THERAPY SYSTEMS:WE HAVE REQUESTED ADDITIONAL INFORMATION FROM THE PATIENT FILE REGARDING THE INCIDENT. UPON COMPLETI
INTRAVASCULAR ULTRASOUND CATHETER VOLCANO CORPORATION:DURING A RENAL ANGIOGRAM, DR PLACED A 6F, 11CM CORDIS AVANTI + SHEATH IN THE GROIN WITH A 260CM PLAT
INTROCULAR LENS STAAR SURGICAL CO.:(B) (4): CONCLUSION (NO DEVICE FAILURE): AT THE CONCLUSION OF THE ORIGINAL INVESTIGATION OPENED FOR
INTRODUCER COOK MEDICAL INCORPORATED:PATIENT CAME IN FOR AN AORTOGRAM. A 6 FR BALKIN SHEATH WAS USED TO DELIVER STENTS AND BALLOONS. TO
INTRODUCER CATHETER COOK, INC.:RAABE INTRODUCER SHEATH DISCONNECTED FROM THE HUB DURING CONTRAST INJECTION. SNARE WAS USED TO RETRI
INTRODUCER SET COOK MEDICAL INC.:TIP OF COOK'S MICROPUNCTURE INTRODUCER SHEATH BROKE OFF IN PATIENT'S LEFT FEMORAL.
INTRODUCER SET EDWARDS LIFESCIENCES, PR:REPORTEDLY, THE INTRODUCER WAS DIFFICULT TO INSERT, ALTHOUGH VESSEL /SKIN WAS PREPARED WITH A SMALL
INTRODUCER WITH GUIDEWIRE TERUMO:INITIAL BILATERAL LOWER EXTREMITY REVASCULARIZATION PERFORMED PT ON (B) (6) 2010. ON POST-OP EVALUAT
INTRODUCER, CATHETER BIOSENSE WEBSTER, INC.:UNABLE TO FLUSH SHEATH. SHEATH'S INNER CANNULA HAD A STRUCTURAL OBSTRUCTION.
INTRODUCER, CATHETER COOK VASCULAR INC.:EQUIPMENT FAILURE: BLEED BACK DEVICE POSSIBLY DETACHED FROM SHEATH.
INTRODUCER, CATHETER, PERCUTANEOUS MEDTRONIC VASCULAR:A FEMORAL IV SITE WAS INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN. AT THE END OF THE CASE THE FEM
INTRUMENT REMOVER MEDTRONIC SOFAMOR DANEK:A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIF
INTUBATING LMA (RESCUE AIRWAY DEVICE) LMA NORTH AMERICA, INC:A PATIENT'S AIRWAY WAS PROTECTED USING A FASTRACH LMA (LARYNGEAL MASK AIRWAY). THE DEVICE IS AN LMA
INTUBATING STYLET TELEFLEX MEDICAL/ HUDSON RCI:DOCTOR ATTEMPTED INTUBATION WITH A 2.5MM MALLINCKRODT UNCUFFED TRACHEAL TUBE CATALOG NUMBER 86222, L
INVACARE 600 INVACARE:IN 2009 AT APPROXIMATELY 2:15 PM, WRITER WAS COMING OUT OF THE DINING ROOM AND WAS WALKING TOWARDS T
INZII CD001 APPLIED MEDICAL:ENDOBAG BROKE WHEN EXTRACTING SPECIMEN.
IOL ALCON LABORATORIES, INC.:PT HAD SURGERY TO REMOVE A CATARACT FROM HER RIGHT EYE. THE INTRAOCULAR LENS WAS FOLDED INTO THE INJ
IOL INSERTER ABBOTT MEDICAL OPTICS:SHEATH CAME OFF THE HANDPIECE ROD DURING USE, THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR AN
IOL INSERTER/INJECTOR BAUSCH & LOMB SURGICAL:ROOT CAUSE: ACCORDING TO THE PHYSICIAN, THE PRIMARY CAUSE OF THE LENS DAMAGE WAS RELATED TO USE OF T
IOL INSERTER/INJECTOR BAUSCH + LOMB SURGICAL:THE PHYSICIAN REPORTS THAT CRYSTALENS TRAILING HAPTIC TORE DURING DELIVERY USING CRYSTALSERT LENS IN
IOL INSERTER/INJECTOR BAUSH & LOMB SURGICAL:THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS IN THE RIGHT E
IPF, GZI, GZJ, IMG CHATTANOOGA GROUP:DEVICE SHUT OFF, FAILING SAFE. PATIENT REPORTED FEELING "A COUPLE OF BEE STINGS". CLINICIAN REPLACED
IPF, GZJ, GZI CHATTANOOGA GROUP:THIS DEVICE IS FOR EXPORT ONLY. COMPLAINANT STATES THAT DEVICE HAS NOT RECEIVED SOFTWARE UPDATE AS R
IRRIGATION, WOUND STRYKER INST.:WHEN IRRIGATING A WOUND, A PIECE OF THE STRYKER IRRIGATOR TUBING WAS NOTED TO HAVE BROKEN OFF.
IRRIGATOR TIP BECTON DICKINSON:IRRIGATOR TIP WAS SQUIRTING OUTSIDE OF IRRIGATOR. PHYSICIAN TRIED TO RETIGHTEN IRRIGATOR TIP ONTO SY
IV BAG B. BRAUN MEDICAL, INC.:B.BRAUN 500ML 0.9% SODIUM CHLORIDE IV BAGS. LOT NUMBER: J9S626. THREE BAGS DEVELOPED LEAKS FROM THE
IV CATH SMITHS MEDICAL ASC:DISTAL 1.4 OF 22G 1" IV CATH DISLODGED IN PATIENT VEIN AFTER FAILED IV ATTEMPT. PATIENT SEEN BRIEFLY
IV CATHETER B. BRAUN, MELSUNGED AG:EMPLOYEE HAD COMPLETED THE IV INSERTION AND HAD WITHDRAWN THE NEEDLE FROM THE CATH -THE IV CATHETER
IV CATHETER BD MEDICAL SURGICAL:IV CATHETER DID NOT RETRACT NEEDLE PROPERLY WHEN INSERTING. DISCONTINUED IV AND STARTED NEW IV IN DI
IV CATHETER BECTON DICKINSON:UPON STARTING AN IV 18 GAUGE 1.16 INCH ANGIOCATH AND OBTAIN LABS, THE TOURNIQUET WAS ON AND "UP". TH
IV CATHETER BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.:INSERTED BD NEXIVA CLOSED IV CATHETER SYSTEM TO PATIENT'S VEIN. AFTER SUCCESSFUL INSERTION OF THE CA
IV CATHETER BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.:THIS REPORT CORRESPONDS TO A PREVIOUS REPORT THAT WAS FILED LAST MONTH. WE HAVE AN ADDITIONAL FOUR
IV CATHETER SMITHS MEDICAL ASD, INC:WHILE ATTEMPTING TO REMOVE THE CATHETER, THERE WAS RESISTANCE AND ONLY THE HUB CAME OUT. THE CATHETE
IV CATHETER SMITHS MEDICAL ASD, INC.:WHEN THE NURSE WENT TO DISCONTINUE THE IV, THE PINK HUB WAS MISSING FROM THE WHITE PLASTIC CATHETER
IV CATHETER UNK:BD NEXIVA CLOSED IV CATHETER SYSTEM CAP CAME OFF OF PT'S IV AND WAS BLEEDING.
IV CATHETER EXTENSION SET BAXTER HEALTHCARE CORP.:TUBING CAME APART FROM CONNECTOR ON BAXTER CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SET OF IV NE
IV FLUID WARMING SET SMITHS MEDICAL:WHEN DISCONNECTING FLUID WARMING SET FROM EXTENSION TUBING, THE END OF THE TUBING CRACKED AND BROKE
IV PUMP BAXTER:ENTERED ROOM FOR ALARMING PUMP TO FIND THE IV TUBING LOADING AREA OPENED, RESET THE TUBE RELEASE TO
IV TUBING CAREFUSION:PATIENT RECEIVING DEXTROSE 5% 1/2 NORMAL SALINE AT 60 ML/HR. IV FLUID NOTED TO BE LEAKING OUT OF HOL
IV TUBING HOSPIRA:RECEIVED A LOT OF IV TUBING FROM HOSPIRA IN WHICH THE PROVIDED CLAMP DOES NOT FIT INTO THE PUMPS UNL
IV TUBING SET ICU MEDICAL:THE IN LINE DRIP CHAMBER FOR THE IV WAS UPSIDE DOWN.
IV TUBING, CONNECTOR, MALE ICU MEDICAL:HUNG DOXORUBICIN, PATIENT ALERTED SHE THOUGHT TUBE WAS LEAKING. STOPPED INFUSION, CHECKED LINES, SPI
IV TUBING, EXTENSION SET CAREFUSION:T-CONNECTOR HAD BEEN SCREWED ON PORT ON INTERNAL JUGULAR CENTRAL VENOUS LINE. THE PIECE OF TUBING TH
IV TUBING, EXTENSION SET, MICRO-BORE SMITHS MEDICAL:I HUNG A NEW ATIVAN DRIP AT 0404. AT APPROXIMATELY 0530 ANOTHER NURSE WAS AT MY BEDSIDE ASSISTING M
IV TUBING, INFUSION SET BARD ACCESS SYSTEMS, INC:RN ACCESSED PORT WITH ACCESS SYSTEM, THEN FOUND PATIENT'S GOWN TO BE SOAKING WET SEVERAL MINUTES LAT
IV TUBING, INFUSION SET CARDINAL HEALTH; CAREFUSION:IV TUBING SPONTANEOUSLLY SNAPPED IN TWO AT THE POINT WHERE THE WHITE DISC (AN ANTI-REFLUX VALVE?) ME
IV TUBING, INFUSION SET CAREFUSION:FLUID LEAKED OUT OF THE TUBING ONTO THE FLOOR WHILE INFUSING VIA INFUSION PUMP. PUMP WAS SENT TO BIO
IV TUBING, Y CONNECTOR ALARIS:RN DISCONNECTED LINE TO DRAW A BLOOD CULTURE. WHEN SHE DID SO THE ENTIRE CAP FELL OFF OF THE Y-SITE
IVC FILTER BARD PERIPHERAL VASCULAR:FLUOROSCOPY IN 2008 FOUND IVC FILTER SEGMENT IN THE RIGHT VENTRICLE. THIS WAS RE-EVALUATED IN (B) (6
IVC FILTER COOK MEDICAL INC.:WHILE TRYING TO DEPLOY A COOK CELECT JUGULAR NAVALIGN IVC FILTER, THE PHYSICIAN WAS UNABLE TO GET TH
IYE AND MUJ TOMOTHERAPY INCORPORATED:ACTUAL SOFTWARE CODE USED IN DEVICE EVALUATED. TOMOTHERAPY CONDUCTED A REVIEW OF THE AMOUNT OF PT MO
IZI (ANGIOGRAPHIC SYSTEM) PHILIPS MEDICAL SYSTEMS:THIS REPORT IS BEING FILED UPON NOTIFICATION FROM OUR X-RAY MFR, TO SUBMIT THIS EVENT THAT HAPPENED
IZI (MOBILE X-RAY SYSTEM) PHILIPS MEDICAL SYSTEMS:THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A F/U REPORT
J-P DRAIN CARDINAL HEALTH:BREAKAGE OF WOUND DRAIN.
JAA (X-RAY FLUOROSCOPIC, IMAGE INTENSIFIED, SYSTEM PHILIPS MEDICAL SYSTEMS:THIS REPORT IS BEING FILED UPON NOTIFICATION FROM OUR X-RAY MFR TO SUBMIT THIS EVENT THAT HAPPENED I
JACKSON TABLE UNK:PT HAD A POSTERIOR LUMBAR INTERBODY FUSION ON (B) (6) 2010. PT WAS POSITIONED PRONE ON A MITZUHO AXI
JAZZY SELECT POWER CHAIR PRIDE MOBILITY PRODUCTS:I OWN A PRIDE JAZZY SELECT POWER CHAIR AND DUE TO THE CONSTRUCTION OF THE DRIVE WHEEL GEAR BOX CONST
JET LAVAGE STRYKER INSTRUMENTS PUERTO RICO:THE DEVICE WAS NOT RECEIVED FOR EVAL. ACCORDING TO THE INFO PROVIDED, THE SURGEON TWISTED OFF THE CO
JKA - BLOOD SPECIMEN COLLECTION DEVCIE SMITHS MEDICAL ASD, INC.,:A REPORT WAS RECEIVED THAT STATED A HOSPITAL EMPLOYEE WAS EXPOSED TO BLOOD WHEN THE DEVICE LEAKED. A
JOH - TRACHEOSTOMY TUBE SMITHS MEDICAL ASD, INC.:CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE
JOH-TRACHEOSTOMY TUBE SMITHS MEDICAL ASD, INC.:THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE
JP DRAIN - CLOSED WOUND SUCTION EVACUATOR KIT - 10 BARD:JP DRAIN SURGICALLY PLACED IN ABDOMEN DURING WHIPPLE PROCEDURE ON (B) (6) 2010. ON REMOVAL ON (B) (6
KIT, BIRTH CONTROL DEVICE, PERMANENT GYRUS ACMI:DURING A HYSTEROSCOPY PROCEDURE, THE FIRST ESSURE FROM THE KIT, WAS APPARENTLY DEFECTIVE WITH A BENT
KIT, CONDUCTION ANESTHETIC CODMAN & SHURTLEFF, INC.:THE PHYSICIAN REPORTED THAT DURING PLACEMENT OF AN AGILE CATHETER IN THE INTRATHECAL SPACE, THE PT J
KIT, TITAN, ASSEMBLY COLOPLAST CORPORATION:NOTES FROM HISTORY AND PHYSICAL: "PATIENT WITH HISTORY OF INFLATABLE PENILE PROSTHESIS PLACEMENT FOU
KNA INSTRUMENT, MANUAL, SPECIALIZED, OBSTETRIC-GYN COOK UROLOGICAL INC:QUOTE FROM PHYSICIAN: I RECENTLY USED A BAKRI BALLOON FOR A DELAYED POSTPARTUM HEMORRHAGE, AND THE B
KNEE INSTRUMENT ZIMMER, INC.:IT IS REPORTED THAT IT WAS UNABLE TO IMPLANT THE NK REVISION TIBIA DUE TO THE FACT THAT THE REAMER G
KNEE INTERPOSITIONAL DEVICE CONFORMIS:PT WITH A KNEE INTERPOSITIONAL DEVICE COMPLAINED OF POSTOPERATIVE PAIN AND WAS RECOMMENDED FOR AN EX
KNEE PROSTHESIS DEPUY ORTHOPAEDICS, INC.:PT WAS REVISED TO ADDRESS PATELLA CLUNKING WITH SOME PAIN.
KNEE PROSTHESIS ZIMMER MANUFACTURING B.V.:REVISION OF LOOSE TIBIA, X-RAYS SHOWED LOOSENING OF THE TIBIA AND AS A RESULT, THE PATIENT WAS REVIS
KNEE PROSTHESIS ZIMMER, INC.:THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
KNEE PROSTHESIS ZIMMER, MANUFACTURING B.V.:DURING A KNEE REVISION SURGERY, THE SURGEON REMOVED THE TIBIAL COMPONENT AND ARTICULAR SURFACE. THE
KNH - DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE CONCEPTUS, INC.:A PHYSICIAN REPORTED THAT HER PATIENT WAS EXPERIENCING PAIN APPROXIMATELY 1 YEAR FOLLOWING AN ESSURE
KNH DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE CONCEPTUS, INC.:A PHYSICIAN REPORTED THAT HIS PT PRESENTED TO HIM WITH BLEEDING FOLLOWING AN ESSURE MICRO-INSERT IMP
KNH-DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE CONCEPTUS, INC.:DURING AN ESSURE MICRO-INSERT IMPLANTATION PROCEDURE IN 2009, A PERFORATION OCCURRED THAT WAS RELATE
KNH-DEVICE,OCCLUSION,TUBAL,CONTRACEPTIVE CONCEPTUS, INC.:MDR IS BEING REPORTED OUTSIDE OF THE 30-DAY TIME FRAME BECAUSE THIS WAS INITIALLY EVALUATED AS NOT R
KNIFE BLADE MEDLINE:PERFORMING BILATERAL LUMBAR LAMINOTOMIES AT L3 AND L4-5 AND END OF PROCEDURE, KNIFE BLADE TIP BROKE
KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WI COOK ENDOSCOPY:EVALUATION: THE PROBE DEVICE WAS RETURNED TO THE APPROVED PROBE SUPPLIER FOR COMPLAINT EVALUATION. T
KNT C. R. BARD INC. (BASD):THE COMPLAINT OF A BREAK IN THE RETENTION DOME IS CONFIRMED. IT SHOULD BE NOTED THAT ONLY THE SEPARA
KNT TUBES, GASTROINTESTINAL AND ACCESSORIES ABBOTT NUTRITION:PER CUSTOMER, THE SET WAS PROBABLY DISCARDED. PER ABBOTT DEVICE PROCEDURES, REASONABLE EFFORTS ARE M
KNT, TUBES GASTROINTESTINAL AND ACCESSORIES ABBOTT NUTRITION:(B) (4): DILATION OF THE STOMA.
KOE DILATOR, URETHRAL COOK UROLOGICAL INC:ONE OPENED PACKAGE CONTAINING A 5FR FACIAL DILATOR WAS RECEIVED. THE DILATOR WAS SEPARATED INTO TWO
KOG, ENDOSCOPE AND/OR ACCESSORIES COOK ENDOSCOPY:EVALUATION: WE COULD NOT CONFIRM THE REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED
KRD DEVICE, EMBOLIZATION, VASCULAR COOK INC.:THE DEVICE WAS USED IN A PEDIATRIC CARDIAC CATH LAB - THEY WERE CLOSING PDA AND THE ORIGINAL COIL, W
KRD DEVICE, EMBOLIZATION, VASCULAR COOK, INC.:THE PHYSICIAN WAS PERFORMING AN ILIAC (INTRA-ARTERIAL INFUSION CHEMOTHERAPY) PROCEDURE. HE USED TWO
KUGEL HERNIA PATCH SURGICAL SENSE, INC.:BILATERAL INGUINAL HERNIA REPAIR WITH PREPERITONEAL IMPLANTATION OF MEDIUM OVAL KUGAL PATCH BILATERA
LACRIMAL TUBE GUNTHER WEISS SCIENTIFIC GLASSBLOWING CO., INC:WHILE INSERTING A NEW GLADSTONE PUTTERMAN TUBE IN THE PATIENT'S RIGHT EYE, THE END OF THE TUBE BROKE
LANCET ROCHE DIAGNOSTICS:CUSTOMER COULD NOT BE CONTACTED TO OBTAIN INFORMATION.
LANCET DEVICE ROCHE DIAGNOSTICS:CALLER STATES, CUSTOMER WAS PRESCRIBED UNSPECIFIED ANTIBIOTICS FOR AN INFECTION AFTER LANCING HIS FI
LANCET DEVICE - FMK ROCHE DIAGNOSTICS:REPORTER ALLEGED THE NEEDLE FROM THE MULTICLIX LANCET DEVICE PROTRUDES OUTSIDE THE END OF THE CAP AF
LANCET DEVICE- FMK ROCHE DIAGNOSTICS:CALLER REPORTS THAT A PROPERLY SEATED LANCET DID NOT RETRACT INTO SOFTCLIX PLUS DEVICE AFTER FIRING,
LAP BAND ALLERGAN:THE PT'S LAP BAND PORT WAS FOUND TO HAVE A FRACTURE IN THE LAP BAND PORT TUBING PRIOR TO BEING HOSPI
LAP BAND ALLERGAN, INC.:PATIENT HAD LAP BAND PLACEMENT FOUR YEARS AGO. THE PHYSICIAN COULD NO LONGER FILL THE LAP BAND. THER
LAP BAND UNKNOWN (LAP BAND NOT ORIGINALLY PLACED AT OUR FAC:PATIENT PRESENTED TO HOSPITAL ED WITH AN ACUTE ABDOMEN AND FREE INTRAPERITONEAL AIR NOTED ON X-RAYS.
LAP BAND VANGUARD:FORTY THREE YEARS OLD FEMALE : LAP BAND PERFORATION OF GASTRIC GREATER CURVATURE, DIFFUSE EXUDATIVE
LAP GRABBER ETHICON:LAPAROSCOPIC CHOLECYSTECTOMY WAS IN PROGRESS WHEN A LAPAROSCOPIC GRABBER MALFUNCTIONED. A PIECE BROK
LAPARASCOPIC STAPLER ETHICON:DURING SURGERY FOR LAPAROSCOPIC COLON RESECTION, SURGEON UTILIZED AN ETHICON EC60A. DEVICE WOULD NOT
LAPAROSCOPE, GENERAL AND PLASTIC SURGERY ETHICON ENDO-SURGERY, LLC.:(B) (4). (B) (4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
LAPAROSCOPIC CLIP APPLIER (DISPOSABLE) DIRECT DRIVE:A FEW MINUTES INTO THE PROCEDURE, DR (B) (6) HAD A BLEEDING VESSEL. HE TRIED TO USE THE 10MM DIRECT
LAPAROSCOPIC GRASPER CAREFUSION 2200, INC.:TINE BROKE OFF GRASPER. PIECE WAS RETRIEVED BY PHYSICIAN. NO PATIENT INJURY.
LAPAROSCOPIC GRASPER MICROLINE PENTAX SURGICAL:WHILE USING THE LAPAROSCOPY INSTRUMENTS FOR A SURGICAL PROCEDURE, A SPARK AND FLAME WAS NOTICED AT T
LAPAROSCOPIC MORCELLATOR ETHICON, INC.:(B) (4). (B) (4) - INSUFFICIENT DRIVE OF DISPOSABLE. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD
LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM ANCHOR PRODUCTS CO.:DURING A LAPAROSCOPIC SPLENECTOMY, ONE OF THE TWO METAL PRONGS FROM THE TISSUE RETRIEVAL SYSTEM BROK
LARGE NEEDLE DRIVER INSUITIVE SURGICAL INC.:A (B) (6) MALE ABOUT TO UNDER GO ROBOTIC ASSISTED LAPAROSCOPIC PROSTATECTOMY, AS REPORTED BY SURGICA
LARGE NEEDLE DRIVER INTUITIVE SURGICAL INC.:A (B) (6) MALE ABOUT TO UNDER GO ROBOTIC ASSISTED LAPAROSCOPIC PROSTATECTOMY, AS REPORTED BY SURGICA
LASER AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILI:SERVICE ENGINEER, CONTRACTED BY AMS, VISITED THE FACILITY AND PERFORMED A QUALITY INSPECTION ON THE
LASER FIBER AMERICAN MEDICAL SYSTEMS:DURING LASER TURP WITH GREENLIGHT LASER FIBER, THE TIP BROKE OFF IN THE PATIENT. THE TIP WAS RETRIEV
LASER FIBER AMERICAN MEDICAL SYSTEMS, INC.:MD STATED THAT THE GREENLIGHT LASER FIBER "EXPLODED" INSIDE THE PATIENT. MD RETRIEVED FIBER PIECES
LASER FIBER, SURGICAL, REUSEABLE LUMENIS, INC.:DURING THE FIRST HALF HOUR OF AN ENDOSCOPIC LASER STONE EXTRACTION, THE LASER FIBER FAILED, REQUIRIN
LASER FOR EYE SURGERY FOR VISION CORRECTION VISX:FOLLOWING LASER SURGERY FOR CORRECTION OF NEARSIGHTEDNESS, PT IMMEDIATELY BEGAN TO SEE DOUBLE WHEN R
LASER INSTRUMENT, SURGICAL, POWERED ALCON - IRVINE TECH CENTER:THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND CONFIRMED THE POWER OUTPUT IS BELOW SPECIFICATIONS.
LASER INSTRUMENT, SURGICAL, POWERED ALCON - IRVINE TECHNOLOGY CENTER:THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND FOUND AN UNSTABLE LASER HEAD. THE LASER E
LASER, HOLMIUM DORNIER MEDTECH AMERICA, INC.:THE MD WAS DOING A CYSTOLITHOPAXY IN THE OR. DURING THE PROCEDURE THE HOLMIUM LASER BEGAN SHUTTING D
LASER, SURGICAL DORNIER MEDTECH AMERICA, INC.:DURING THE PROCEDURE, THE HOLMIUM LASER, EQUIPPED WITH A 270 MICRON FIBER AND SET AT 600 JOULES, 10
LASER, SURGICAL, CO2 LUMENIS, INC.:REPORT OF PATIENT HAVING CAUTERY PROCEDURE OF HER VAGINAL CONDYLOMA AND EXCISION OF VULVAR CONDYLOMA
LASER-SHIELD 11 TUBE MEDTRONIC XOMED:A (B) (6) FEMALE CAME TO OUR FACILITY FOR HER THIRD LARYNGOSCOPY WITH LASERING OF STENOSIS. A LASER-
LASERS SPECTRANETICS CORP.:FAILURE TO PROVIDE INFORMATION AS REQUIRED.
LASIK LASIK:HAD LASIK SURGERY IN RIGHT EYE. I'M ALMOST BLIND IN THE "CORRECTED" EYE AND AM TOLD BY DOCTOR THAT T
LASIK NA:I UNDERWENT LASIK EYE SURGERY IN 2006. SINCE THE SURGERY, I HAVE SUFFERED FROM A NUMBER OF SEVERE CO
LASIK NOT APPROPRIATE:IT APPEARS THAT AS A CONSEQUENCE OF PRK -INCREASED EYE PRESSURE DURING THE PROCEDURE, I DEVELOPED 2
LASIK UNK:I HAD LASER VISION CORRECTION SURGERY WITH DR (B) (6) IN (B) (6). POST-SURGERY, I HAD DRY EYE PROBLE
LASIK LASER BAUSCH & LOMB:HAD LASIK SURGERY ON BOTH EYES ON THE SAME DAY. POST-OPERATIVELY, I HAVE HAD TO HAVE A CORNEAL TRANS
LCP CONDYLAR PLATES SYNTHES ELMIRA:PT'S FAMILY MEMBER REPORTED THAT THE PT EXPERIENCED PAIN AFTER IMPLANT OF AN LCP PLATE. X-RAY SHOWED
LDF ELECTRODE, PACEMAKER, TEMPORARY BIOSENSE WEBSTER, INC. (IRWINDALE):ACCORDING TO THE FACILITY'S ELECTROPHYSIOLOGY LAB, THE PATIENT STABILIZED AND RECOVERED FROM THIS EV
LEAD SORIN BIOMEDICA CRM S.R.L.:(B) (4); SUBCLAVIAN CRUSH; (B) (4): LEAD WAS SENSING NOISE. A RESPONSE FROM THE MANUFACTURER IS PEND
LEAD SHIELD, CEILING SUSPENDED TI-BA ENTERPRISES, INC.:PATIENT WAS DRAPED AND PREPPED FOR A PROCEDURE. MD WENT TO ADJUST THE SUSPENDED LEAD SHIELD INTO POS
LEAD, DEFIBRILLATION BOSTON SCIENTIFIC -CARDIAC PACEMAKERS, INC:THE PATIENT'S ICD WAS INTERROGATED BECAUSE OF MULTIPLE INAPPROPRIATE SHOCKS. NO VENTRICULAR ARRHYTH
LEAD, DEFIBRILLATION BOSTON SCIENTIFIC CARDIOVASCULAR DIVISION:THE PATIENT WAS RECENTLY SEEN IN OUR ICD CLINIC AT WHICH TIME THE PATIENT'S DEVICE WAS DISCOVERED TO
LEAD, DEFIBRILLATION MEDTRONIC:THE HISTORY AND PHYSICAL NOTES THE FOLLOWING: THE PATIENT HAD A BIVENTRICULAR ICD IMPLANTED 33 MONTH
LEAD, DEFIBRILLATION MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT:THE PATIENT HAS A HISTORY OF COMPLETE HEART BLOCK SECONDARY TO VENTRICULAR SEPTAL DEFECT REPAIR AND
LEAD, DEFIBRILLATION ST. JUDE MEDICAL:THE PATIENT WAS SCHEDULED FOR MINIMALLY INVASIVE AORTIC VALVE REPLACEMENT. HOWEVER, ANALYSIS OF HIS
LEAD, DEFIBRILLATION ST. JUDE MEDICAL CARDIAC RHYTHM:THE PATIENT HAD A BIVENTRICULAR ICD IMPLANTED THREE MONTHS AGO. ROUTINE FOLLOW-UP SHOWED A HIGH PAC
LEAD, LEFT VENTRICULAR MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT:THE HISTORY AND PHYSICAL NOTES THE FOLLOWING: THE PATIENT HAD A BIVENTRICULAR ICD IMPLANTED 33 MONTH
LEAD, OCCIPITAL NERVE MEDTRONIC NEUROMODULATION:THIS PATIENT HAS A HISTORY OF BILATERAL OCCIPITAL NEURALGIA, PREVIOUSLY TRIALED SUCCESSFULLY WITH OC
LEAD, PACEMAKER BOSTON SCIENTIFIC:THE PHYSICIAN ATTEMPTED TO INSERT THE LEAD INTO THE INTRODUCER AND WAS UNABLE TO. A 7-FRENCH PEEL-AW
LEAD, PACEMAKER ST. JUDE MEDICAL:INFORMATION FROM THE HISTORY AND PHYSICAL FROM RECENT VISIT: THE PATIENT WAS ADMITTED DUE TO SEVERE
LEAD, PACEMAKER ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI:THE CARDIOLOGIST WAS IMPLANTING A PERMANENT PACEMAKER WITH ATRIAL AND VENTRICULAR LEADS. A PECTORAL
LEFT VENTRICULAR ASSIST THORATEC CORP.:THE PT REMAINS ON LVAD SUPPORT WITH THE REPLACEMENT PUMP AND NO FURTHER ISSUES HAVE BEEN REPORTED. T
LEFT VENTRICULAR ASSIST THORATEC CORPORATION:THE PT REMAINS ON LVAD SUPPORT WITH THE REPLACEMENT PUMP. THE EXPLANTED DEVICE WAS RETURNED TO THE M
LEFT VENTRICULAR ASSIST DEVICE THORATEC CORP:THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT
LEFT VENTRICULAR ASSIST DEVICE THORATEC CORP.:PT REMAINS ONGOING WITH THE NEW LVAD. THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTH
LEFT VENTRICULAR ASSIST DEVICE THORATEC CORPORATION:THE LVAD HAS BEEN HELD UP IN THE HOSPITAL'S PATHOLOGY. THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE
LEFT VENTRICULAR ASSIST DEVICE VENTRACOR, INC. (NOTE CO. NOW DEFUNCT):THE PT WAS AT HOME WHEN HE FELL AND SHEARED OFF THE ELECTRICAL DRIVELINE CONNECTED TO HIS IMPLANTED
LEFT VENTRICULAR ASSIST DEVICE (LVAD) THORATEC:THE PATIENT CAME INTO THE HOSPITAL WITH A PORTABLE HEARTMATE II DEVICE (LVAD). THE NURSE WAS WITH T
LENS 18.0 SA60AT - LOG169297 ALCONOX INC.:AN INTRAOCULAR LENS WAS NOTED TO BE CRACKED AFTER INSERTING IT INTO THE EYE SAC. ADD'L VISCOELASTIC
LENS CARE DISINFECTING SOLUTIONS ALCON - FORT WORTH / ALCON LABORATORIES, INC.:A CONSUMER REPORTED THAT SHE EXPERIENCED KERATITIS, PAIN AND VISION IMPAIRMENT WITH USE OF THIS PROD
LENS CARE DISINFECTING SOLUTIONS ALCON - FORT WORTH/ ALCON LABORATORIES, INC.:ADVERSE EVENTS: RETINA SCARRING, PSEUDOMONAS AERUGINOSA. AN ATTORNEY REPORTED HIS CLIENT WAS DIAGNOS
LENS CARE DISINFECTING SOLUTIONS ALCON - FORT WORTH/ALCON LABORATORIES, INC.:EVAL SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RECEIVED FOR EVAL. IT IS UNK
LENS GUIDE ALCON RESEARCH LTD. / HUNTINGTON:THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVAL. PRODUCT HISTORY REC
LENS GUIDE ALCON RESEARCH, LTD. / HUNTINGTON:THE CARTRIDGE WAS RETURNED. THE TIP WAS DAMAGED. EVALUATION INDICATED THE CARTRIDGE MAY NOT HAVE BEE
LENS GUIDE ALCON RESEARCH, LTD./ HUNTINGTON:THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVAL. PRODUCT HISTORY REC
LENS INJECTOR BAUSCH & LOMB, INC.:THE BAUSCH & LOMB LENS INJECTOR WAS NOT FUNCTIONING PROPERLY. IT BENT THE HAPTICS ON THE LENSES. P
LENS, INTRAOCULAR ALCON LABORATORIES, INC.:PATIENT SCHEDULED TODAY FOR REPOSITIONING OF THE IOL. DOCTOR REMOVED THE IOL DUE TO A BROKEN HAPTIC
LENSES, SOFT CONTACT, DAILY WEAR CIBA VISION PUERTO RICO, INC.:THIS CASE IS CONSIDERED AS A POSSIBLE INFECTIOUS CORNEAL ULCER. NO PRODUCT HAS BEEN RETURNED. A MANU
LENSES, SOFT CONTACT, EXTENDED WEAR PT CIBA VISION BATAM:THIS EVENT IS CONSIDERED AS AN INFECTIOUS CORNEAL ULCER. AS THERE WAS NO PRODUCT RETURNED OR LOT INF
LENSES, SOFT CONTACT, EXTENDED WEAR PT. CIBA VISION BATAM:EYE CARE PROFESSIONAL REPORTED A PT EXPERIENCED KERATITIS, LEFT EYE, WHICH RESOLVED WITH PRODUCT REM
LENSES, SOFT CONTACTS, EXTENDED WEAR PT. CIBA VISION BATAM:THIS EVENT IS CONSIDERED AS A POSSIBLE INFECTIOUS CORNEAL ULCER DUE TO REPORT OF ULCER WITH PRESUMED
LESNS, SOFT CONTACT, EXTENDED WEAR PT CIBA VISION BATAM:EYE CARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED A SEVERE CORNEAL ULCER LAST MONTH. FOLLOW
LEUKOGUARD RS LEUKOCYTE REMOVAL FILTER FOR SALVAGE ENSATEC, S.A. DE C.V.:IT WAS REPORTED THAT A PATIENT EXPERIENCED A HYPOTENSIVE REACTION DURING SURGERY TO REPAIR AN ABDOMI
LFL INSTRUMENT, ULTRASONIC SURGICAL ETHICON ENDO-SURGERY, LLC:IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS, THE WHITE TISSUE PAD FELL OFF, AND IT IS
LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS:(B) (4). "MOVEMENT DISORDER".
LGW MEDTRONIC NEUROMODULATION:THE IMPLANTABLE NEUROSTIMULATOR BECAME INFECTED AND WAS REPLACED 3 MONTHS AFTER IMPLANTED. ADDITIONA
LIFEPAK 15 MEDTRONIC:ON (B) (6) 2010, (B) (6) FIRE RESCUE UNIT R52 RAN A CARDIAC CALL WITH E63 RUN # 02004. THE PATIENT W
LIFESHIELD Y-TYPE MICROBORE EXTENSION SET HOSPIRA:BABY BORN ON (B) (6) 2009, AT GESTATION (B) (6) WAS IN THE NICU RECEIVING MULTIPLE MEDICATIONS USING
LIFT, PATIENT, NON-AC-POWERED ARJO HOSPITAL EQUIPMENT AB:AS STATED IN INCIDENT EVALUATION FORM: STAFF MEMBERS STARTING TO UNHOOK THE SLING FROM THE LIFT WHEN
LIFT, PATIENT, NON-AC-POWERED ARJO MED AB LTD.:ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.
LIFT, PATIENT, NON-AC-POWERED ARJO MED. AB LTD.:ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
LIFT, PATIENT, NON-AC-POWERED BHM MEDICAL, INC.:THE ONLY WAY THE DETACHMENT COULD OCCUR IS: DURING THE HOOKING UP OF THE STRAP LOOPS TO THE SPREADER
LIGAMAX J & J ETHICON:LIGAMAX APPLIER DID NOT RELEASE CLIP AFTER CLIPPING. DATES OF USE: (B) (6) 2010. DIAGNOSIS OR REASON
LIGAMAX J&J ETHICON:LIGAMAX CLIPS DID NOT RELEASE. DATES OF USE: (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: ENDOSCOPIC P
LIGAMAX JOHNSON & JOHNSON, ETHICON:JOHNSON AND JOHNSON ETHICON LIGAMAX LOCKED UP AFTER 6 CLIPS. DATES OF USE: (B) (6) 2010 - (B) (6) 20
LIGAMAX JOHNSON AND JOHNSON:JOHNSON AND JOHNSON ETHICON LIGAMAX PRODUCT USED IN CASE FIRED A SINGLE CLIP THEN WOULD NOT FIRE MOR
LIGASURE COVIDIEN MEDICAL PRODUCTS VALLEYLAB:VALLEYLAB LS1500 USED BY DR (B) (6) WOULD NOT WORK WHEN PLUGGED IN. THIS SIGNIFICANTLY DELAYED CASES
LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER 5MM VALLEY LAB/DIVISION OF TYCO HEALTHCARE GROUP:LIGASURE DEVICE NOT SEALING CORRECTLY THEREBY CAUSING BACK BLEEDING. DEVICE DID NOT STOP BLEEDING AN
LIGASURE IMPACT (TISSUE FUSION INSTRUMENT) COVIDIEN - VALLEYLAB:PHYSICIAN PERFORMED A VAGINAL HYSTERECTOMY USING A VALLEYLAB LIGASURE IMPACT DEVICE. AFTER THE PROCE
LIGASURE VESSEL SEALING INSTRUMENT, LS1037 STERILMED INC:DURING THE USE OF A REPROCESSED -STERILMED- LIGASURE LS1037 WAS PLACED INSIDE THE PT AND THE LIGASUR
LIGASURE VESSEL SEALING SYSTEM COVIDIEN LLC (SHANGHAI):THE CUSTOMER REPORTED THAT DURING A HEMICOLECTOMY, THE DEVICE WAS WORKING FINE AND THEN WOULD NO LON
LIGASURE VESSEL SEALING SYSTEM COVIDIEN LP (US SURGICAL):THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVALUATIO
LIGASURE VESSEL SEALING SYSTEM COVIDIEN LP (VALLEYLAB):THE CUSTOMER REPORTED THAT AN LS1500 WAS USED IN A PROCEDURE INVOLVING A PATIENT DEATH. THE SITE HAS
LIGATING LOOP DELIVERY SYSTEM, CHROMIC GUT COVIDIEN UNITED STATES SURGICAL CORPORATION:SUTURE WASN'T ATTACHED TO DEVICE PROPERLY AND DIDN'T DEPLOY. DISCOVERED PRIOR TO USE ON PATIENT.
LIGATOR, ESOPHAGEAL BOSTON SCIENTIFIC - MARLBOROUGH:THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION A
LIGATOR, ESOPHAGEAL BOSTON SCIENTIFIC - SPENCER:IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LI
LIGHT MAT LUMITEX:PATIENT UNDERWENT CYSTOCELE REPAIR WITH MESH. WHEN DRAPES WERE TAKEN OFF OF THE PATIENT, A QUARTER S
LIGHT SOURCE OLYMPUS AMERICA:PT IN GI SUITE (B) (6) 2009 FOR UPPER ENDOSCOPY; PT TRANSFERRED TO ICU POST-PROCEDURE WHERE PT DEVEL
LIMB EXTENSION STENT GRAFT ENDOLOGIX, INC.:ADDITIONAL DEVICE INFORMATION: MODEL NO. 16-16-55L LOT NO. W09-2745-007, EXPIRATION DATE: 10/01/2012
LINEAR ACCELERATOR VARIAN MEDICAL SYSTEMS:THE EVAL CONSISTS OF RESEARCHING SEVERAL VARIAN COUCH MODELS. FOLLOWING A RISK HAZARD EVAL, IT WAS D
LINEAR ACCELERATOR SOFTWARE VARIAN MEDICAL SYSTEMS:IT WAS REPORTED THAT THE MLC LEAF PARAMETER VALUES ARE HIGHLIGHTED IN ORANGE COLOR ON THE 4D INTEGRA
LINER / JDH SMITH & NEPHEW, INC.:IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION.
LIQUID EMBOLIC EV3 NEUROVASCULAR:THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT.
LIQUID OXYGEN RESERVOIR PLAINFIELD-LOX-RX:THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. PRODUCT MANUAL WARNS, "OXYGEN SUPPLIED FROM THIS EQ
LIT/DQY BARD PERIPHERAL VASCULAR, INC.:THE LOT NUMBER HAS BEEN PROVIDED AND A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFO
LITHOTRIPTOR PROBE OLYMPUS AMERICA INC.:DURING THE USE OF A LOANER OLYMPUS NEPHROSCOPE AND AN OLYMPUS ULTRASONIC LITHOTRIPTOR WITH PROBE, ME
LITHOTRIPTOR, BILIARY MECHANICAL BOSTON SCIENTIFIC - SPENCER:(B) (6), GENDER AND WEIGHT ARE UNKNOWN. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT
LKK MDT PUERTO RICO OPERATIONS CO, JUNCOS:IT WAS CONFIRMED THAT THE PT HAD EXPERIENCED INCREASED PAIN. IT WAS CONFIRMED THROUGH A CONTRAST DYE
LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS:.
LKK MEDTRONIC NEUROMODULATION:LITERATURE: WARD A, HAYDEN S, DEXTER M, SCHEINBERG A. CONTINUOUS INTRATHECAL BACLOFEN FOR CHILDREN W
LLZ-SYSTEM, IMAGE PROCESSING, RADIOLOGICAL PACS STRYKER IMAGING:ACCORDING TO THE INITIAL REPORTER, PTS HAD TO BE RE-IMAGED (X-RAYED). THE DEVICE IN QUESTION WAS EVA
LNH (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) PHILIPS MEDICAL SYSTEMS:CONCLUSIONS - MOST LIKELY THE PT PUT HER FINGER BETWEEN THE TABLE TOP AND THE MAGNET COVER. IT IS KN
LOCKING SCREW SYNTHES (USA):ADDITIONAL INFO HAS BEEN REQUESTED. MFR, 501K AND MANUFACTURE DATE CANNOT BE DETERMINED WITHOUT A LO
LOCKING SCREWS SYNTHES (USA):INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LO
LOVENOX, 30 MG AVENTIS:GAVE LOVENOX DOSE TO PT AND THEN ENGAGED SAFETY MECHANISM. GLASS VIAL INSIDE THE SYRINGE BROKE OFF A
LOW AIRLOSS THERAPY HILL-ROM CHARLESTON:HILL-ROM HAD BECOME AWARE OF A PT WHO ALLEGEDLY FELL OUT OF A FLEXICAIR MC3 LOW AIRLOSS THERAPY BED.
LOW PRESSURE CUFFED TRACHEOSTOMY TUBE COVIDIEN:LEAK IN TRACH CUFF BALLOON NOTED BY RESPIRATORY THERAPIST. TRACH REQUIRED REPLACEMENT. DIAGNOSIS OR
LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, BOSTON SCIENTIFIC:IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF
LPL - LENSES, SOFT CONTACT, DAILY WEAR COOPERVISION MANUFACTURING, LTD.:EVALUATION: AN INVESTIGATION INTO THIS MATTER IS ONGOING. A REVIEW OF THE COMPLAINTS HISTORY FOR THI
LPM-LENSES, SOFT CONTACT, EXTENDED WEAR COOPERVISION MANUFACTURING, LTD.:EVAL: A REVIEW OF THE COMPLAINTS HISTORY FOR THIS DEVICE WAS PERFORMED AND FOUND NO OTHER COMPLAINTS
LSZ VENTILATOR, HIGH FREQUENCY CAREFUSION:THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RES
LTI IMPLANT, INTRAGASTRIC FOR MORBID OBESITY OBTECH MEDICAL SARL:INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE REMAINS IMPLANTED PORT RE
LTV 1000 CARDINAL HEALTH PULMONETIC SYSTEMS:VENTILATOR CIRCUIT WAS CHANGED ON A PULMONETIC LTV 1000 VENTILATOR AT 8:30 AM; RESPIRATORY THERAPIST
LTV SERIES VENTILATOR BATTERY PULMONETIC SYSTEMS, INC.:PULMONETIC SYSTEMS LTV SERIES VENTILATOR BATTERIES -(B) (4)- HAVE A DESIGN FLAW WITH THEIR NEW BATTE
LUBRICATED LATEX CONDOMS DUREX CONSUMER PRODUCTS INC.:AFTER WEARING THE DUREX PLEASURE CURVE CONDOM, MY NOCTURNAL ERECTIONS WERE PAINFUL DURING ONE NIGHT
LUMBAR CATHETER MEDTRONIC NEUROSURGERY:IT WAS REPORTED THAT TWO ATTEMPTS WERE MADE TO INSERT A SUBARACHNOID DRAIN PRIOR TO SURGERY. NO GUID
LUMBAR CATHETER CLOSED TIP INTEGRA NEUROSCIENCES:APPROXIMATELY ONE INCH OF A LUMBAR CATHETER TIP BROKE OFF IN THE PATIENT WHILE ATTEMPTING TO PULL TH
LV LEAD BIOTRONIK SE & CO. KG:PER ECHO-CRT ADVERSE EVENT REPORT, THIS CXR SHOWED A LIKELY LEAD DISLODGEMENT. AS THIS LEAD HAS DISL
LV LEAD BIOTRONIK SE & CO KG:PER OOS, THIS LEAD WAS REPOSITIONED TWICE BUT COULD NOT REMOVE THE DIAPHRAGMATIC STIMULATION. THIS L
LV LEAD BIOTRONIK SE & CO. KG:THIS SYSTEM WAS REMOVED DUE TO INFECTION AND VEGETATION ON THE LEADS. THE SYSTEM WAS LATER REPLACED
LV LEAD BIOTRONIK SE & CO. KG.:PER (B) (4) ADVERSE EVENT REPORT, THIS PT EXPERIENCED A LARGE PERICARDIAL EFFUSION. "DELAYED IMPLANT
LVAD THORATEC:PER PATIENT'S MOTHER: PATIENT WAS ALIVE/SLEEPING AT 6 AM, FOUND UNRESPONSIVE AT 10 AM, NO VENTRICULA
LVAD THORATEC CORPORATION:MAJOR PUMP UNIT(S) INVOLVED: BLOOD PUMP.BEARING WEAR.SPECIFIC COMPONENT(S) INVOLVED: PUMP DRIVE UNIT
LVAD BATTERY CLIP THORATEC CORPORATION:THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND ARE CURRENTLY BEING ANALYZED. NO FURT
LVAD CONTROLLER THORATEC CORPORATION:THE PT WAS IMPLANTED WITH A VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINAT
LVAD SYSTEM CONTROLLER THORATEC CORP.:THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD C
LVAD SYSTEM CONTROLLER THORATEC CORPORATION:THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ACCORDING TO THE VAD COORDINATOR
LX-C EV3, INC.:UPON REMOVING THE TURBOHAWK FOR CLEANING, THE DEVICE GOT CAUGHT IN PINNACLE SHEATH CAUSING THE TIP O
LXB COCHLEAR BONE ANCHORED SOLUTIONS:PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY IN 2009 DUE TO SKIN OVERGROWTH AROUND THE FIX
LZH, PUMP, INFUSION, ENTERAL ABBOTT NUTRITION:(B) (4): THE EVALUATION CONFIRMED A CRACKED/FAILED POWER CORD PLUG. (B) (4)
MAC BLADE EVALUEMED/TRI-ANIM DISTRIBUTER:DISPOSABLE LARYNGOSCOPE BLADE BROKE DURING INTUBATION. THE PART THAT BROKE IS THE SECTION THAT CONNE
MAF STENT, CORONARY BOSTON SCIENTIFIC:IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS O
MAF STENT, CORONARY BOSTON SCIENTIFIC CORPORATION:IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE A FAILURE ANALYSIS OF THE C
MAGNETIC RESONANCE DIAGNOSTIC DEVICE HITACHI MEDICAL CORP.:ON (B) (6) 2010, HITACHI WAS MADE AWARE OF THE EVENT, BUT WAS NOT AWARE OF THE PT INJURY. THAT SAME
MAGNITUDE MRI PATIENT MONITORING SYSTEM INVIVO CORPORATION:THE AVAILABLE INFO DOES NOT INDICATE THAT THE MONITOR MALFUNCTIONED, AND THERE IS NO INDICATION THAT
MAIN BODY GRAFT APPLICATOR COOK MEDICAL:VALVE ON COOK ZENITH ENDOVASCULAR SHEATH FAILED AND PATIENT LOST BLOOD AFTER SHEATH WAS REMOVED. REQ
MALE SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC.:PATIENT CLAIMS "URINARY LEAKAGE, PERMANENT PAIN AND MULTIPLE INFECTIONS DUE TO THE INVANCE PROCEDURE
MALIS BIPOLAR IRRIGATING FORCEPS CODMAN & SHURTLEFF, INC.:AFFILIATE REPORTED THAT THE PT'S LIP WAS BURNED DURING A TONSILLOTOMY. IT WAS A THIRD DEGREE BURN ON
MAMMARY PROSTHESIS MENTOR:ALLERGIC REACTIONS (RASH, ITCHING).
MAMMOSITE MULTI LUMEN CATHETER HOLOGIC/CYTIC SURGICAL PRODUCTS:INACCURATE MEASUREMENT OF TREATMENT DISTANCE FOR MULTILUMEN CATHETER. RADIOACTIVE SOURCE PLACED 10 C
MANUAL HOSPITAL BED HILL-ROM RITTER:THE ACCOUNT INDICATES THAT THE BRAKE CASTER WAS REPLACED TO REPAIR THE BED.
MANUAL OPHTHALMIC SURGICAL INSTRUMENT ALCON PRECISION DEVICE - SINKING SPRING:INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECE
MANUAL, SURGICAL INSTRUMENT BIOMET SPORTS MEDICINE:IT WAS REPORTED THAT PATIENT UNDERWENT ACL PROCEDURE UTILIZING A FEMORAL AIMER TIP ON (B) (6) 2009.
MANUFACTURED FLOOR PASSIVE LIFT BHM MEDICAL, INC.:ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
MARISSA LIFT ARJO INC.:NUT CAP DISASSEMBLED FROM SPREADER BAR ON ARJO MARISSA LIFT ALLOWING THE RESIDENT TO FALL.
MARKED SPRING TIP GUIDEWIRE CONSOLIDATED MEDICAL EQUIPMENT COMPANY:IT WAS REPORTED THAT "DURING EGD MD NOTICED RESISTANCE AS MOVING #54 FR. AMERICAN DILATOR OVER GUIDE
MASS SPECTROMETER, CLINICAL USE WATERS CORP:THIS REPORT RELATES TO THE WATERS QUATTRO PREMIER XE MASS SPECTROMETER (QUATTRO PREMIER) INSTALLED A
MATERIAL, IMPRESSION PENTRON CLINICAL TECHNOLOGIES:IT WAS REPORTED THAT AS A RESULT OF THE IMPRESSION MATERIAL NOT SETTING, THE PATIENT SWALLOWED THE P
MATERNAL CARE HILL-ROM RITTER:ACCOUNT CLEANED THE HEAD SECTION DRIVE PARTS TO RESOLVE THIS ISSUE. PURSUANT TO OUR RESPONSE TO WARN
MATRIX MANDIBLE SCREWS SYNTHES (USA):PATIENT HAD A 4CM ANGIOBLASTOMA OF THE LEFT POSTERIOR MANDIBLE. THE PATIENT WAS SCHEDULED FOR A RESE
MAX, MQP SPINAL ELEMENTS, INC.:CONCLUSIONS: "NO DEVICE FAILURE". DR. (B) (6) STATED THAT THERE IS NOTHING WRONG WITH THE DEVICE. "U
MCM COCHLEAR LTD:PER THE CLINIC, THE PATIENT¿S INTERNAL MAGNET WAS DISLODGED DUE TO AN IMPACT TO THE HEAD. THE PATIEN
MCX CATHETER, CORONARY, ARTHERECTOMY BOSTON SCIENTIFIC:SAME CASE AS MFR REPORT #: 2134265-2010-00146, 2134265-2010-00145. FOLLOWING ARTERIAL PLACEMENT OF A
MCX CATHETER, CORONARY, ATHERECTOMY BOSTON SCIENTIFIC:IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE
MCX CATHETER, CORONARY, ATHERECTOMY BOSTON SCIENTIFIC CORPORATION:IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF
MECHANICAL VENTILATOR COVIDIEN:PATIENT HAD BEEN ON VENTILATOR IN CATH LAB. NO ISSUES NOTED. PATIENT WAS DISCONNECTED FROM VENT FOR
MECHANICAL VENTILATOR COVIDIEN PURITAN BENNETT:IT IS STANDARD OPERATING PROCEDURE AT THIS INSTITUTION TO HARD-WIRE CONNECT ALL MECHANICAL VENTILATO
MECHANICAL VENTILATOR GE HEALTHCARE VERSMED:VENTILATOR ALARM SOUNDED, DISPLAY SHOWING "LOW OXYGEN." PATIENT'S OXYGEN SATURATION SHOWED BETWEEN L
MED SURGICAL HILL-ROM RITTER:THE TECH FOUND THE METAL TAB SECURING TREND ROD AND TUBE ASSY IN PLACE BENT OUT NOT HOLDING ASSY IN
MED/SURG BED STRYKER MEDICAL:BRAKE FAILURE. CASTERS ROLLED AT 45 POUNDS OF FORCE. BRAKE HOLDING SPECIFICATION IS 50 POUNDS. BE
MEDICAL PARTICAL CHARGED RAD. THERAPY VARIAN MEDICAL SYSTEMS:IT WAS REPORTED THAT DURING A SCHEDULED ONCOLOGY TREATMENT, THE OBI KVD COVER FELL OFF DURING CBCT I
MEDICATION ACUTE CARE CART LIONVILLE SYSTEMS, INC:STAFF REPORTED MED CART WOULD NOT HOLD A CHARGE. BIOMED CHECKED/REPLACED THE BATTERY. UNIT STILL W
MEDIPORT BARD MEDICAL:DURING ROUTINE PORT CHECK, IT WAS DISCOVERED THE PORT HAD FRACTURED AND WAS LYING IN THE RIGHT ATRIU
MEDITRACE CADENCE MULTIFUNCTION ADULT PRECONNECT TYCO HEALTHCARE GROUP LP:DURING A CODE BLUE, ONE OF THE NURSES INVOLVED IN THE RESUSCITATION OF THE PT WENT TO CHANGE OUT THE
MEDTRONIC INFUSION PUMP MEDTRONIC NEUROMODULATION:MORE PAIN THAN USUAL WHEN PUMP WAS WORKING, DIFFICULTY SLEEPING. PUMP WAS REMOVED AND REPLACED IN 20
MEDTRONIC MOSAIC PORCINE AORTIC VALVE MEDTRONIC HEART VALVES:(B) (6) UNDERWENT A AORTIC VALVE REPLACEMENT WITH A 27 MM MEDTRONIC MOSAIC AORTIC PORCINE BIOPROSTHE
MELLEN NELLCOR - PUREITAN BENNETT:UPON ENTERING THE PATIENT'S ROOM, THE VENTILATOR HAD A MENU SCREEN UP. I HAVE NEVER SEEN THIS SCREEN
MESH C.R. BARD, INC.:MESH FAILED AND CAUSED A RECURRENT HERNIA.
MESH ETHICON, INC.:AFTER SEVERAL UNSUCCESSFUL ATTEMPTS AT MESH REVISION, THE PATIENT SOUGHT EVALUATION AND TREATMENT OF
MESH (FTL) ETHICON INC. (ETHICON):PT EXPERIENCED BLOOD AND WATER VAGINALLY. AT 6 DAYS LATER, PT FOUND THAT MESH RUPTURED THROUGH VAGIN
MESH SURGICAL ETHICON, INC.:(B) (4) - DYSPAREUNIA: CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBT
MESH TVO SLING AMERICAN MEDICAL SYSTEMS:ON (B) (6) 2007, I HAD THE AMERICAN MEDICAL SYSTEMS MONARC SUBFASCIAL HAMMOCK MESH INSERTED INTO MY
MESH, HERNIA C.R. BARD, INC:PATIENT WITH A HISTORY OF A HARTMANN PROCEDURE FOR PERFORATED DIVERTICULITIS AND CLOSURE OF COLOSTOM
MESH, SURGICAL ETHICON, INC.:THICKENED ENDOMETRIUM. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED,
MESH, SURGICAL , POLYMERIC ETHICON, INC.:NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3
MESH, SURGICAL POLYMERIC ETHICON, INC.:(B) (4). (PAIN) - : CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE O
MESH, SURGICAL, POLYMERIC BOSTON SCIENTIFIC - MARLBOROUGH:THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THER
MESH, SURGICAL, POLYMERIC ETHICON, INC.:IT WAS REPORTED THAT THE PATIENT UNDERWENT A SLING PROCEDURE IN 2007 FOR THE TREATMENT OF URINARY IN
METAL ACETABULAR LINER / NXT SMITH & NEPHEW ORTHOPAEDICS, LTD.:IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED TO REMOVE A DISASSOCIATED ACETABULAR LINER. THE
METASUL HEAD 28 M 12/14 ZIMMER GMBH:IT WAS REPORTED THAT PT HAD TO BE REVISED DUE TO LOOSENING.
METASUL LARGE DIAMETER HEAD 42/H ZIMMER GMBH:IT WAS REPORTED THAT REVISION WAS NECESSARY DUE TO A COBALT ALLERGY. HIP PAIN STARTED APPROXIMATELY
METASUL LARGE DIAMETER HEAD 50/P ZIMMER GMBH:CONCLUSION: THE QUALITY RECORDS INDICATE THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, MEASUREMENTS,
MHX DRT PHILIPS MEDICAL SYSTEMS:A PT DIED AT THIS INSTITUTION AND THE USERS REPORTED THAT 'POSSIBLY ALARMS DID NOT GO OFF".
MHX, DRT AGILENT TECHNOLOGIES, INC.:THE CUSTOMER REPORTED THAT THE NURSES DID NOT HEAR AN ALARM DURING A PATIENT INCIDENT.
MHX, DRT PHILIPS MEDICAL SYSTEMS:THE CUSTOMER REPORTED A LACK OF ALARMING WHICH OCCURRED DURING A PT EXPERIENCING A FOUR-SECOND CARDI
MHX,DRT PHILIPS MEDICAL SYSTEMS:THE CUSTOMER REPORTED THAT AN ASYSTOLE ALARM DID NOT SOUND AT THE CENTRAL STATION FOR A PATIENT IN D
MIC GASTROSTOMY FEEDING TUBE KIMBERLY CLARK:PT HAD TO HAVE G-TUBE REPLACED BECAUSE OF A MALFUNCTION AND LEAKING. PT HAD GASTROSTOMY TUBE QUESTIO
MIC TRANSGASTRIC - JEJUNAL FEEDING TUBE KIMBERLY CLARK HEALTHCARE:TUBE FEEDING HOOKED UP TO INCORRECT PORT AND INFUSION INITIATED. SUGGEST PORTS BE LABELED ON TWO SID
MICRO DRILL STRYKER:WHILE DOCTOR WAS DRILLING A TOOTH, THE DRILL BEGAN SHAKING, RATTLING, SPRAYING HOT OIL AND BURNED TH
MICRON FILTER HOSPIRA, INC.:MICRON FILTERS THAT CAN BE USED FOR EITHER MEDICATION THERAPY OR TOTAL PARENTERAL NUTRITION (TPN) AD
MICROPUNCTURE SET MEDCOMP:METHOD: RECORD REVIEW. RESULTS: A REVIEW OF THE MANUFACTURING RECORDS INDICATED ALL DEVICE SPECIFICA
MICROSCOPE SLIDE FOR CYTOLOGY HOLOGIC, INC.:ABNORMAL CELLS FOUND OUTSIDE OF 22 FIELDS OF VIEW (FOV). NO TRIGGER CELLS WERE PRESENT WITHIN 22 FOV
MICROTEST MULTI-MICROMEDIA (H1N1 SWAB) REMEL:PATIENT SWABBED PER GUIDELINES FOR RULE OUT. SWAB INSERTED INTO RIGHT NARE BY RN. UPON REMOVAL OF SW
MICROTOUCH PLUS GLOVES ANSELL:ICU STAFF REPORTED FAULTY GLOVES. THE GLOVES WERE WEAK AND WERE BREAKING EASILY WITH MULTIPLE HOLES.
MICROWAVE ABLATION ACCESSORY COVIDIEN LP (VALLEYLAB):THE SITE REPORTS THAT THE ANTENNA WAS DISCARDED. THE IFU STATES: ENSURE THE RADIATING SECTION IS ALW
MICROWAVE DELIVERY SYSTEM UROLOGIX, INC.:PT EXPERIENCED A VASOVAGAL REACTION DURING A TRANSURETHRAL MICROWAVE TREATMENT. THE TREATMENT WAS ST
MICROWAVE ENDOMETRIAL ABLATION MICROSULIS MEDICAL LTD.:PT WAS TREATED WITH A DISPOSABLE MEA APPLICATOR. THE PT RETURNED ONE DAY POST MEA WITH COMPLAINT OF
MICROWAVE ENDOMETRIAL ABLATION DEVICE MICROSULIS MEDICAL LTD.:THE MEA SYSTEM RECORDS DATA FOR EACH PT TREATMENT PROCEDURE, INCLUDING SYSTEM PARAMETERS AND PT DATA
MID-URETHRAL SLING BOSTON SCIENTIFIC:DURING A SURGICAL PROCEDURE, AN OBTRYX SYSTEM HALO LIGATURE FOR ATTACHMENT TO SLING BROKE. THE PHYSI
MIDDLE EAR IMPLANT VIBRANT MED-EL HEARING TECHNOLOGY GMBH:IT WAS REPORTED THAT THE PT WAS IMPLANTED WITH A VIBRANT SOUNDBRIDGE, DUE TO A BILATERAL SENSORINEUR
MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM W.L. GORE & ASSOCIATES:ON (B) (6) 2008, THE PT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN AND A RUPTURED ULCERATION OF
MIH / STENT, ENDOVASCULAR GRAFT, AORTIC ANEURYSM T W. L. GORE & ASSOCIATES:A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE HAS BEEN CONDUCTED. RESULTS - A REVIEW OF THE M
MIH / SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM T W. L. GORE & ASSOCIATES:ON (B) (6) 2009, THE PT WAS IMPLANTED WITH TWO (B) (4) EXCLUDER AAA ENDOPROSTHESES TO TREAT AN INFRA
MIH / SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM T W.L. GORE & ASSOCIATES:IN 2009, THIS PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTH
MIH / SYSTEM, ENDOVASCULAR GRAFT AORTIC ANEURYSM T W.L. GORE & ASSOCIATES,INC:A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. THE MANUFACTURING RECORDS REVIEW VERIFIED
MIH / SYSTEM, ENDOVASCULAR GRAFT, AORITC ANEURYSM W.L. GORE & ASSOCIATES:A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. THE MANUFACTURING RECORDS REVIEW VERIFIED
MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM W. L. GORE & ASSOCIATES:A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWOR
MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM W. L. GORE & ASSOCIATES, INC.:A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWOR
MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM W.L. GORE & ASSOCIATES:IN 2008, THE PATIENT WAS IMPLANTED WITH GORE TAG THORACIC ENDOPROSTHESIS. NINE DAYS LATER, THE PATIE
MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM W.L. GORE & ASSOCIATES, INC:ON (B) (6) 2010, THE PATIENT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS FOR TREATMENT OF
MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM W.L. GORE & ASSOCIATES, INC.:IN 2009, THIS PATIENT WAS IMPLANTED WITH THREE GORE TAG THORACIC ENDOPROSTHESES TO TREAT A THORACIC
MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM W.L. GORE & ASSOCIATES,INC:IN 2009, THIS PT WAS IMPLANTED WITH TWO GORE TAG THORACIC ENDOPROSTHESES TO TREAT A 5.5 CM SACCULAR
MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC, ANEURYSM W. L. GORE & ASSOCIATES:A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWOR
MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR COOK INC:EVENT EVALUATION: STILL UNDER INVESTIGATION.
MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR COOK INC.:NO PRODUCT OR IMAGES RETURNED TO ASSIST WITH THIS INVESTIGATION. THE DEVELOPMENT OF THE ZENITH DEVIC
MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR COOK, INC:A (B) (6) MALE PATIENT WITH KIDNEY DISEASE, CEREBROVASCULAR DISEASE, HIGH BLOOD PRESSURE, AORTIC VAL
MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR COOK, INC.:A MALE PT UNDERWENT AAA REPAIR IN 2009. THE PT RECEIVED A ZENITH MAIN BODY AND TWO ZENITH ZT ILIAC L
MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR W. L. GORE & ASSOCIATES:IN 2005, THIS PT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER E
MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR W.L. GORE & ASSOCIATES:A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS
MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR WILLIAM COOK EUROPE:(B) (4). INVESTIGATION: THE RETURNED DEVICE APPEARED TO HAVE BEEN MANIPULATED WITH AN EXCESSIVE FORC
MIH, SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM T COOK, INC.:(B) (4). EVENT IS STILL UNDER INVESTIGATION AT THIS TIME.
MIH, SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM T W.L. GORE & ASSOCIATES:A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWOR
MIH/ SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM T W. L. GORE & ASSOCIATES, INC.:ON (B) (6) 2003, THIS PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH TWO GORE EXCLUDER AA
MIH/ SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM T W.L. GORE & ASSOCIATES:A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWOR
MIH/ SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM T W.L. GORE & ASSOCIATES,INC:ON (B) (6) 2008, THE PATIENT WAS TREATED FOR AN ANEURYSM IN THE DESCENDING THORACIC AORTA WITH A GOR
MIH/ SYSTEM, ENODVASCULAR GRAFT, AORTIC ANEURYSM T W.L. GORE & ASSOCIATES:THE TGT3710 DEVICE HAS BEEN RETURNED FOR AN ENGINEERING EVALUATION. THE EVENT WITH THE ORIGINALLY IM
MIH/SYSTEM , ENDOVASCULAR GRAFT, AORTIC ANEURYSM T W. L. GORE & ASSOCIATES:IN 2007, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC AN
MIH/SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM TRE W.L. GORE & ASSOCIATES:IN 2006, THE PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN INFRARENAL AORTIC AN
MIH/SYSTEM, ENDOVASCULAR GRAFT AORTIC ANEURYSM TRE W. L. GORE & ASSOCIATES:ON (B) (6) 2005, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH TWO GORE EXCLUDER AAA
MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR W. L. GORE & ASSOCIATES:ON (B) (6) 2008, THIS PATIENT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN AB
MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR W.L. GORE & ASSOCIATES:IN 2008, THE PT WAS TREATED FOR A RUPTURED THORACIC AORTIC ANEURYSM WITH TWO GORE TAG THORACIC ENDOP
MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR W.L. GORE & ASSOCIATES, INC:ON (B) (6) 2010, THIS PATIENT UNDERWENT SURGERY FOR BLEEDING FROM AN ULCERATED AREA THAT MAY HAVE ER
MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR W.L. GORE & ASSOCIATES, INC.:A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS
MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR W.L. GORE & ASSOCIATES,INC:A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWOR
MILLER 4 DISPOSABLE LARYNGOSCOPE BLADE MEDICAL DEVICES PVT. LTD:CARDIAC ARREST PT REQUIRED INTUBATION. THE EMERGENCY MEDICAL TECHNICIAN/PARAMEDIC (EMT/P) ATTEMPTED
MINI BAG BAXTER HEALTHCARE CORP.:MINI BAG DID NOT WORK TO MIX THE MEDICATION PROPERLY. WHEN TAB WAS BROKEN OFF TO MIX THERE IS ON OBS
MINI ENDOSCOPE, GASTROENTEROLOGY-UROLOGY BOSTON SCIENTIFIC - MARLBOROUGH:MINI BAG DID NOT WORK TO MIX THE MEDICATION PROPERLY. WHEN TAB WAS BROKEN OFF TO MIX THERE IS ON OBS
MINI MAXTORQUE CANNULATED SCREWS ORTHOHELIX SURGICAL DESIGN:DRIVER EITHER BROKE OR STRIPPED DURING A CASE.
MINI MAXTORQUE CANNULATED SCREWS ORTHOHELIX SURGICAL DESIGNS:THE DEVICE WAS DISPOSED AT THE USER FACILITY, AND NO POSSIBILITY OF RETRIEVAL FOR EVALUATION IS POSS
MINI VISION ABBOTT VASCULAR, INC.:MD PLACED COR WIRE DOWN 100% AFFECTED ARTERY. BALLOON DILATATION PERFORMED SLIGHT STAIN NOTICED, NO
MIRAGE QUATTRO FFM SYS XSML-AMER RESMED LTD.:THE MASK WAS NOT RETURNED TO RESMED FOR EVAL. BASED ON INFO AVAILABLE, RESMED IS UNABLE TO CONFIRM T
MIRAGE SWIFT RESMED LTD.:THE DEVICE INVOLVED IN THIS EVENT IS NOT ALLEGED TO BE FAULTY AND WAS NOT RETURNED TO RESMED FOR EVA
MIRAGE SWIFT II RESMED LTD.:A SLEEP LAB REPORTED TO RESMED THAT ONE OF THEIR PTS OBTAINED A 2ND DEGREE CHEMICAL BURN ON THEIR FA
MITEK VAPORWAND DEPUY MITEK:VAPORWAND (MITEK) SAFETY FEATURE DID NOT ACTIVATE AND SHUT OFF WHEN IT GOT CLOSE TO TELESCOPE, AND T
MITEK VAPR 3 DEPUY MITEK:ON (B) (6) 2010, A (B) (6) MALE WAS ADMITTED FOR LEFT SHOULDER ARTHROSCOPIC DEBRIDEMENT. DURING THE
MLV / OCCLUDER, TRANSCATHETER / SEPTAL W.L. GORE & ASSOCIATES:A REVIEW OF THE MFG RECORDS HAS BEEN CONDUCTED. THE EXPLANTED DEVICE WAS DISCARDED BY THE USER FACIL
MLV / OCCLUDER, TRANSCATHETER SEPTAL W.L. GORE & ASSOCIATES:IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED A 30MM GORE HELEX SEPTAL OCCLUDER TO CLOSE AN ASD (ATRI
MLV/OCCLUDER, TRANSCATHETER SEPTAL W.L. GORE & ASSOCIATES:A REVIEW OF THE MFG RECORDS HAS BEEN CONDUCTED. THE REVIEW OF THE MFR RECORDS VERIFIED THAT THIS LOT
MOBILE LIFT ARJO MED AB LTD:ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
MODIFICATION TO DYNESYS SPINAL SYSTEM ZIMMER GMBH:THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
MODULAR MONITORS GE HEALTHCARE:CUSTOMER REPORTED THE SOLAR MONITOR DID NOT ALARM WHEN A PT EXPERIENCED LOW SPO2 FOLLOWING ORTHOPEDI
MODULE PACK PHILIPS HEALTHCARE:THE PT WAS ADMITTED WITH ACUTE WHEEZE, ASTHMA, AND CONGENITAL CYANOTIC HEART DISEASE WITH A HISTORY
MOGEN CIRCUMCISION CLAMP UNK:THIS MALE PT HAD THE TIP OF HIS GLANS ACCIDENTALLY AMPUTATED IN THE COURSE OF A CIRCUMCISION USING A
MONITOR PHILIPS ELECTRONICS NORTH AMERICA CORP.:THE ALARMING MECHANISM ON A PHILIPS PT CARE MONITOR AND OXIMETER PULSE-OX SYSTEM, WHILE IN USE ON PT
MONITOR SYSTEM, HEMODYNAMIC PHILIPS HEALTHCARE:XPER HEMODYNAMIC CATH SYSTEM, INFORMATION MANAGEMENT (IM) UPGRADED TO 1.3.1 ON NOVEMBER 3. ON NOVEMB
MONITOR, BLOOD PRESSURE, TRANDUCER HOSPIRA:THE SAFESET TUBING SEPARATED FROM THE SAFESET SAMPLING PORT. THIS HAS HAPPENED ABOUT THREE TIMES, B
MONITOR, CENTRAL STATION PHILIPS MEDICAL SYSTEMS:A NON PHILIPS KEYBOARD WAS INSTALLED. THE SUBSTITUTE KEYBOARD HAD A MUTE FUNCTION ON IT AND THE PHIL
MONITOR, FETAL PHILIPS MEDICAL SYSTEMS:THIS ISSUE HAS BEEN IDENTIFIED SEVERAL TIMES IN THE PAST WITH DIFFERENT PATIENTS. THIS SPECIFIC EVEN
MONITOR, PHYSIOLOGICAL DRAEGER MEDICAL SYSTEMS, INC.:AFTER THE RUNNING 15-30 MINUTES, THE MONITOR POWERED OFF AND RESTARTED AUTOMATICALLY AFTER 30-60 SEC
MONITOR, PHYSIOLOGICAL GE HEALTHCARE:THE AC PLUG FOR A PATIENT MONITOR OVERHEATED TO THE POINT OF GENERATING VISIBLE SMOKE. HEATING SEEM
MONITOR, PHYSIOLOGICAL PHILIPS MEDICAL SYSTEMS:PATIENT'S OXYGEN LEVELS WERE CHANGED AND PATIENT WAS DESATURATING. THE PATIENT'S OXYGEN PERCENTAGE S
MONITOR, PHYSIOLOGICAL, DATA BASE SERVER PHILIPS MEDICAL SYSTEMS:WE HAVE A CERNER EMR SYSTEM THAT IS CONNECTED TO A PHILIPS PATIENT MONITORING SYSTEM TO CHART VITAL
MONITOR, TELEMETRY TRANSMITTER GE HEALTHCARE:TELEMETRY RHYTHM WAS NOT BEING PICKED UP BY THE MONITOR. LEADS WERE CHANGED AND THE TELEMETRY BOX WA
MONITOR, TELEMETRY, TRANSMITTER GE HEALTHCARE:PATIENT WAS ADMITTED TO ROOM A JUST AFTER HIS ROOMMATE WAS ADMITTED TO B (SAME ROOM). THE TELEMETRY
MONITOR, VITAL SIGNS CRITICARE SYSTEMS, INC.:STAFF ENTERED PATIENT'S ROOM FOR VITAL CHECK. WHEN THE PULSE OXIMETER SENSOR WAS APPLIED TO THE PAT
MONITOR, VITAL SIGNS GE HEALTHCARE:USER NOTICED THAT POWER CORD WAS BURNING AND IMMEDIATELY UNPLUGGED FROM WALL AC RECEPTACLE.
MONITORING ELECTRODE 3M HEALTHCARE:BASED ON THE INFO REPORTED, 3M HAS DETERMINED THAT USER ERROR AND FAILURE TO FOLLOW INSTRUCTIONS RES
MONOBLOCK TIBIA ZIMMER TMT:REVISION OF THE TIBIA (TMT'S COMPONENT) WAS PERFORMED DUE TO A LOOSENING OF THE FEMORAL COMPONENT (N
MONOFOCAL INTRAOCULAR LENS ABBOTT MEDICAL OPTICS:IT WAS REPORTED THE LENS WAS IMPLANTED AND REMOVED DURING THE SAME SURGERY. CAPSULE TORE AND VITRECT
MONOFOCAL IOL ABBOTT MEDICAL OPTICS:THE INTRAOCULAR LENS WAS REMOVED AND REPLACED WITHOUT COMPLICATION DUE TO THE PATIENT'S COMPLAINT OF
MONOFOCAL LENS ABBOTT MEDICAL OPTICS:THE IOL WAS RECEIVED AND THE DIOPTER MEASURED CORRECT AS LABELED. THE LENS MET ALL MANUFACTURING SP
MONOPOLAR CURVED SCISSORS INTUITIVE SURGICAL:DURING THE DAVINCI INSTRUMENT ARM CLEANING PROCESS, IT WAS NOTED THAT ONE COMPLETE SIDE OF THE MONOP
MONTHLY DISPOSABLE CONTACT LENSES, -7.50, BC 8.6 CIBA VISION:CIBA VISION AIR OPTIX NIGHT & DAY -FORMERLY BRANDED FOCUS NIGHT & DAY- CONTACT LENSES CAUSED SIGNIFI
MORCELLATOR ETHICON, INC.:(B) (4) - TISSUE JAM: CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN REC'D, HOWE
MOTOR DRIVE UNIT, MORCELLATOR GYNECARE WORLDWIDE, A DIVISION OF ETHICON, INC.:PATIENT ADMITTED FOR LAPROSCOPIC SUPRACERVICAL HYSTERECTOMY. PT HAD LARGE FIBROID TUMORS AND UTERUS.
MOTOR, DRILL, PNEUMATIC MEDTRONIC:THE MD WAS USING THE DISSECTING ROUTER WHEN THE DRILL BIT DROVE STRAIGHT THROUGH THE FOOT PLATE AND
MOTOR, DRILL, PNEUMATIC STRYKER INSTRUMENTS KALAMAZOO:IT WAS REPORTED THAT DURING A CRANIOTOMY, A GREENISH FLUID LEAKED FROM THE DURAGUARD ATTACHMENT INTO
MOTOR, DRILL, PNEUMATIC STRYKER INSTRUMENTS, INSTRUMENTS DIV:NEUROSURGEON WAS USING MAESTRO DRILL TO TURN CRANIAL BONE FLAP DURING CRANIOTOMY AND TUMOR RESECTION
MOTORIZED WHEELCHAIR HOVEROUND CORP.:THE MOTORIZED WHEELCHAIR WAS NOT RETURNED TO HOVEROUND; HOWEVER, NO MALFUNCTION SUSPECTED. REPORTER
MOTORIZED WHEELCHAIR HOVEROUND CORPORATION:NO MALFUNCTION OF MOTORIZED WHEELCHAIR SUSPECTED. ACCORDING TO THE (B) (6) REPORT, THE END USER WAS
MPC SCISSORS ALCON LABORATORIES INC.:PT WITH PROLIFERATIVE DIABETIC RETINOPATHY WITH TRACTION FOVEAL DETACHMENT FROM VITREAL FOVEAL TRACT
MRI G.E.:MRI (B) (6) 2009. DURING MRI, PT EXPERIENCED WARMING IN PELVIS AND LEFT ARM. PROCEDURE HAD TO BE STO
MRI GE MEDICAL SYSTEMS, LLC:PATIENT TAKEN FOR MRI FROM THE TELEMETRY UNIT. ELECTRODES WERE NOT REMOVED PRIOR TO TRANSFERRING THE
MRI IMAGING COIL, TORSO XL PHILIPS MEDICAL SYSTEMS:AFTER I FINISHED SCANNING THE PATIENT, A RED AREA WAS NOTICED ON THE PATIENT'S CHEST AND ABDOMEN ARE
MRI POWER INJECTOR SYSTEM LIEBE-FLARSHEIM CO:PENDING INVESTIGATION. UPON RECEIPT TO INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE S
MRI SLEEVE TOPSPINS, INC.:DURING MRI OF THE CHEST, A MOMENTARY FLAME OR "FLASH" AND SMOKE WERE OBSERVED COMING FROM SLEEVES TH
MRI, 1.5T GE MEDICAL SYSTEMS, LLC:PATIENT WAS IN MRI FOR CERVICAL SPINE MRI. DURING TEST SHE INFORMED THE TECH THAT SHE FELT A BURNIN
MRI, 1.5T PHILIPS MEDICAL SYSTEMS:AFTER I FINISHED SCANNING THE PATIENT, A RED AREA WAS NOTICED ON THE PATIENT'S CHEST AND ABDOMEN ARE
MRI, 3T PHILIPS MEDICAL SYSTEMS:PATIENT WAS GETTING AN MRI SCAN INVOLVING HER PELVIS WHEN PATIENT COMPLAINED OF A BURNING SENSATION
MRI, 3T SIEMENS MEDICAL SOLUTIONS:A CEILING LIGHT FIXTURE LOCATED ABOVE THE MRI CAUGHT FIRE. THE MRI TEAM MEMBERS DEPRESSED THE MRI Q
MRM - DEFIBRILLATOR, IMPLANTABLE, DUAL - CHAMBER ELA MEDICAL:THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. REVIEW OF THE
MRM - DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER ELA MEDICAL:RECORDED EPISODE IN DEVICE MEMORY WERE REVIEWED DURING THE FOLLOW-UP OF THIS DEVICE. IN 2007, 2 VENT
MRM - DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER SORIN CRM:FOLLOWING THE PT'S DEATH, THE DEVICE WAS EXPLANTED. BASED ON THE DATA COLLECTED, IT SEEMS THAT AN FV
MRM DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER ELA MEDICAL:THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE US. DEVICE F/U FILES WERE ANALYZED. C
MRM DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER SORIN BIOMEDICA C.R.M., S.R.L.:THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE U.S. THE DEVICE MODEL INVOLVED IN THI
MRM DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER SORIN CRM:THE DEVICE INVOLVED IN THIS REPORT HAS DELIVERED INAPPROPRIATE SHOCKS, DUE TO OVERSENSING OF NOISE.
MRM, DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER SORIN CRM:(B) (4): BATTERY DEPLETION WAS CONFIRMED AND RESULTED FROM THE NUMEROUS DELIVERED SHOCK THERAPIES. T
MRM-DEFIBRILLATOR, IMPLANTABLE, DUAL CHAMBER ELA MEDICAL:THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. REVIEW OF THE
MRM-DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMB ELA MEDICAL:DURING THE FOLLOW UP 6 WEEKS AFTER IMPLANTATION, THE PHYSICIAN OBSERVED SOME RECORDED EPISODES WITH
MRM-DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER ELA MEDICAL:THE ICD INVOLVED IN THIS MDR REPORT WAS IMPLANTED IN 2007. SIX MONTHS LATER, THE PT RECEIVED ONE INA
MRM-DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER ELE MEDICAL:AFTER A SYSTEM REVISION (NOT OBJECT OF THE CUSTOMER COMPLAINT REPORT), THERE WAS SOME DIFFICULTIES T
MRM-DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER SORIN CRM:DURING A ROUTINE FOLLOW-UP INTERROGATION, THE ICD SHOWED OPEN CONTINUITY ON THE SVC COIL. AN INTERVE
MS-30 FEMORAL STEM ZIMMER GMBH:(B) (4). CONCLUSION: THE INVESTIGATION SHOWS, THAT THE CAUSE OF THE BREAKAGE WAS FATIGUE. THERE ARE
MTP FUSION PLATE TORNIER/NEXA:PATIENT HAD HARDWARE REMOVED FROM LEFT FOOT THAT WAS FOUND BROKEN. THE METATARSOPHALANGEAL (MTP) FU
MULTI FIRE ENDO GIA 30 TYCO HEALTH CARE:PHYSICIAN WAS UNABLE TO GET THE AUTO SUTURE DEVICE TO STAPLE CORRECTLY - UNABLE TO DEPLOY STAPLES.
MULTI-AXIAL SCREW WARSAW ORTHOPEDIC INC.:(B) (4): THE SCREW WAS NOT RETURNED FOR EVAL. IMAGING FILMS HAVE NOT BEEN PROVIDED. WITH THE AVAILAB
MULTI-LINK MINI VISION CORONARY STENT SYSTEM ABBOTT VASCULAR:WHILE PLACING A STENT INTO ONE OF THE CORONARY ARTERIES, STENT DETACHED FROM SHEATH AND PROCEEDED TO
MULTI-LUMEN CVC KIT ARROW:UPON REMOVAL OF CENTRAL VENOUS GUIDEWIRE, RESISTANCE WAS MET. WHEN THE GUIDEWIRE WAS REMOVED, IT APP
MULTI-PARAMETER PATIENT MONITOR GE HEALTHCARE:ACCORDING TO THE CUSTOMER, ON (B) (6) 2010 AT 10:10 AM AT ICU (B) (6), A PT HAD A RUN OF V-TACH, THE
MULTIFOCAL INTRAOCULAR LENS ABBOTT MEDICAL OPTICS:THE PATIENT REPORTED ATTEMPTS TO REMOVE THE INTRAOCULAR LENS WERE UNSUCCESSFUL AND IT REMAINS IMPLAN
MULTIFOCAL IOL ABBOTT MEDICAL OPTICS:IT WAS REPORTED THE LENS WAS EXPLANTED WITHOUT COMPLICATION DUE TO THE PATIENT'S INTOLERANCE OF HALO
MULTIFOCAL IOL ALCON:UNACCEPTABLE VISUAL ACUITY WITH MULTIFOCAL INTRA-VASCULAR LENS IMPLANT, LEFT EYE. INSERTED IN 2009 B
MULTIPARAMETER MODULE SPACELABS MEDICAL, INC.:DEVICE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. SPACELABS HAS REQUESTED THAT THE SUSPECT DEVICE
MYELOGRAM TRAY 22G X 3.5 CONTRAST MEDIUM CAREFUSION:THE INTERVENTIONAL RADIOLOGIST WAS USING THE SAFETY PROCEDURE OF SCOOPING UP THE NEEDLE CAP AND THEN
MYSTIQUE PLATE MEDTORNIC SOFAMOR-DANEK:I HAD AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PERFORMED IN 2008 WITH USE OF THE "MYSTIQUE" PLATE
N' VISION MEDTRONIC:PT WITH HISTORY OF TROPICAL SPASTIC PARAPARESIS WITH INTRATHECAL BACLOFEN PUMP PLACEMENT IN 2009. FO
N9C0075 COVIDIEN:FIRED WHITE LOAD ACROSS THICK TISSUE AND HEARD CRACK. INSTRUMENT WOULD NOT UNLOAD CARTRIDGE.
NA 3M HEALTH CARE:PRODUCT LABELING STATES THE EXPECTED AES WITH PRODUCT USE IN THE WARNING SECTION SHOWN BELOW. WARNIN
NA BOSTON SCIENTIFIC:IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS OCCURRED. THE INDEX PR
NA DEPUY ORTHOPAEDICS, INC.:THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAMINATION. THE PRODUCT CODE
NA INTEGRA LUXTEC, INC.:OPERATING ROOM MATERIALS MANAGER AND RISK MANAGER REPORTED THAT A PT WAS BURNED (3RD DEGREE BLISTERI
NA NA:I HAD LASIK SURGERY IN (B) (6) 2003. MY DOCTOR WAS (B) (6) IN (B) (6). I HAD HALOS THE FIRST FEW DAY
NA NORTH HAVEN - USS:PROCEDURE: ROUX-EN-Y. ACCORDING TO THE REPORTER: NO PROBLEMS WERE REPORTED DURING THE CASE. (B) (6),
NA PHILIPS MEDICAL SYSTEMS:THIS CUSTOMER REPORTED THAT SHE WAS BOOTED OUT OF THE RETROSPECTIVE REVIEW OF THE 96 HOURS OF ECG DA
NA PROCTOR & GAMBLE:WHILE CHEWING FOOD, PRODUCT OOZES FROM UNDER DENTURES, MIXES WITH MY FOOD AND CAUSES MY STOMACH TO A
NA SIEMENS HEALTHCARE:FIVE PTS WERE REPORTED TO HAVE ELEVATED TROPONIN LEVELS, BUT ACTUALLY HAD NORMAL TROPONIN LEVELS. IN
NA SMITH & NEPHEW:AS A RESULT OF HAVING A SURGICAL SCREW PLACED IN LEG TO REPAIR A TORN ACL. THE DOCTOR PLACED A BIO-D
NA STRYKER ORTHOPAEDICS CORK:THE INFO IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPT. NO ADD'L INFO IS AV
NA STRYKER SPINE BORDEAUX:THE PT WITH STENOSIS HAD PLIF ON L5 - S1 AND HAD ADDITIONAL SCREW ON S2 FOR REINFORCEMENT ON (B) (6)
NAIL / JDS BROOKS MANUFACTURING SITE:.
NAIL / JDS BROOKS MFG SITE:NA
NAIL / JDS GERMANY MANUFACTURING SITE:NA
NAIL / JDS SMITH & NEPHEW INC.:WHILE IMPLANTING A NAIL, IT WAS REPORTED THAT SURGERY TIME WAS EXTENDED DUE TO SCREWDRIVER/SCREW MIS
NAIL / JDS SMITH & NEPHEW, INC.:IT WAS REPORTED THAT A FOREIGN MATERIAL WAS NOTICED ON THE INNER TYVEK SHEET OF A NAIL'S PACKAGING.
NAIL DROP / MDM BROOKS MANUFACTURING SITE:IT WAS REPORTED THAT THE DEVICE FRACTURED CAUSING SURGERY TIME TO BE EXTENDED BY APPROX 45 MINS.
NAIL, TROCHANTERIC STRYKER TRAUMA GMBH:PHYSICIAN WAS PLACING A SHORT GAMMA NAIL IN PATIENT WHEN LOCKING SCREW USING TARGETER THAT COMES WIT
NAIL/JDS BROOKS MANUFACTURING SITE:IT WAS REPORTED THAT THE NAIL FRACTURED REQUIRING A REVISION SURGERY TO CORRECT.
NANOKNIFE IRREVERSIBLE ELECTROPORATION ANGIODYNAMICS:BRADYCARDIA, HYPOXIA, ASYSTOLE ADDED FROM AN EMAIL DATED JANUARY 13, 2010 FROM GORDON SINGLE THIS IS
NASAL DRESSING POLYGANICS BV:THE PRODUCT HAS NOT BEEN RECEIVED FOR INVESTIGATION, NOR WAS ADDITIONAL INFORMATION RECEIVED. IF FUR