UNKNOWN
Report
- Report Number
- 3002808486-2016-01349
- Event Type
- Injury
- Date Received
- November 8, 2016
- Report Date
- October 22, 2016
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
(B)(4). CATALOG #: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. EXPIRATION DATE: UNKNOWN AS LOT # IS UNKNOWN. SINCE CATALOG # IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374 OR K090140. MFR DATE UNKNOWN AS LOT # IS UNKNOWN. INVESTIGATION IS STILL IN PROGRESS.
(B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. PMA 510(K): SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374 OR K090140. MFG DATE: 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 IF FURTHER INFORMATION IS RECEIVING WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56.
DESCRIPTION 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 INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
DESCRIPTION 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 INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 737829 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |