UNKNOWN
Report
- Report Number
- 3002808486-2019-00041
- Event Type
- Death
- Date Received
- January 9, 2019
- Report Date
- July 12, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). MFR SITE) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) (B)(4). INVESTIGATION IS STILL IN PROGRESS. 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.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). D4) CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK CELECT FILTER E3) OCCUPATION: NON-HEALTHCARE PROFESSIONAL G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. 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 IF FURTHER INFORMATION IS "RECEIVING" WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56.
INVESTIGATION ¿ INVESTIGATION REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. PER QUALITY ENGINEERING REVIEW, THE ADDITIONAL INFORMATION PROVIDED FOR THIS COMPLAINT DOES NOT CHANGE THE PREVIOUS INVESTIGATION CONCLUSION. THEREFORE, NO NEW INVESTIGATION ACTIVITIES WILL BE CONDUCTED AT THIS TIME. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. 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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE, OR UNCHANGED.
PATIENT ALLEGEDLY RECEIVED AN IMPLANT VIA THE RIGHT INTERNAL JUGULAR FEMUR VEIN ON (B)(6) 2011 DUE TO DEEP VEIN THROMBOSIS (DVT).
DESCRIPTION OF EVENT ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT [PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2011. PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS DECEASED. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23644 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |