UNKNOWN
Report
- Report Number
- 3002808486-2017-00781
- Event Type
- Death
- Date Received
- March 14, 2017
- Report Date
- February 25, 2017
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- ATTORNEY
Narratives
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). A2) UNKNOWN AS INFORMATION WAS NOT PROVIDED. A4) UNKNOWN AS INFORMATION WAS NOT PROVIDED. B3) UNKNOWN AS INFORMATION WAS NOT PROVIDED. D1) UNKNOWN AS INFORMATION WAS NOT PROVIDED. D4) LOT#: UNKNOWN AS INFORMATION WAS NOT PROVIDED. CATALOG#: UNKNOWN BUT REFERRED TO AS AN IVC FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. D6) UNKNOWN AS INFORMATION WAS NOT PROVIDED. F9) UNKNOWN AS LOT# IS UKNOWN. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. H4) UNKNOWN AS LOT# IS UNKNOWN. (B)(4). IT HAS NOT BEEN POSSIBLE TO INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE. COOK WILL REOPEN ITS INVESTIGATION AFTER FURTHER INFORMATION IS RECEIVED AND WILL SUPPLEMENT IN ACCORDANCE WITH 21 C.F.R.803.56 WHEN APPROPRIATE. IT IS UNKNOWN, IF REPORTED PATIENT DEATH IN ANY WAY RELATED TO THE FILTER. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IT IS ALLEGED THAT "[PT] WAS IMPLANTED WITH AN IVC FILTER AND SUFFERED PRE-DEATH INJURIES AND/OR DEATH." PATIENT OUTCOME: ALLEGED THAT [PT] "HAVE SUFFERED PERMANENT AND CONTINUOUS INJURIES, PAIN AND SUFFERING, DISABILITY AND IMPAIRMENT. [PT] HAVE SUFFERED EMOTIONAL TRAUMA, HARM AND INJURIES THAT WILL CONTINUE INTO THE FUTURE. [PT] HAVE LOST THEIR ABILITY TO LIVE A NORMAL LIFE, AND WILL CONTINUE TO BE SO DIMINISHED INTO THE FUTURE. FURTHERMORE, [PT] HAVE LOST EARNINGS AND WILL CONTINUE TO LOSE EARNINGS INTO THE FUTURE AND HAVE MEDICAL BILLS BOTH PAST AND FUTURE RELATED TO CARE BECAUSE OF THE IVC FILTERS¿ DEFECTS." [PT] IS DECEASED. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
(B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS AN IVC FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IT IS ALLEGED THAT "[PT] WAS IMPLANTED WITH AN IVC FILTER AND SUFFERED PRE-DEATH INJURIES AND/OR DEATH." PATIENT OUTCOME: ALLEGED THAT [PT] "HAVE SUFFERED PERMANENT AND CONTINUOUS INJURIES, PAIN AND SUFFERING, DISABILITY AND IMPAIRMENT. [PT] HAVE SUFFERED EMOTIONAL TRAUMA, HARM AND INJURIES THAT WILL CONTINUE INTO THE FUTURE. [PT] HAVE LOST THEIR ABILITY TO LIVE A NORMAL LIFE, AND WILL CONTINUE TO BE SO DIMINISHED INTO THE FUTURE. FURTHERMORE, [PT] HAVE LOST EARNINGS AND WILL CONTINUE TO LOSE EARNINGS INTO THE FUTURE AND HAVE MEDICAL BILLS BOTH PAST AND FUTURE RELATED TO CARE BECAUSE OF THE IVC FILTERS¿ DEFECTS." [PT] IS DECEASED. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 186125 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |