UNKNOWN
Report
- Report Number
- 3002808486-2016-00082
- Event Type
- Injury
- Date Received
- March 1, 2016
- Report Date
- February 12, 2016
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
THIS EVENT HAS ALSO BEEN SUBMITTED TO FDA UNDER MANUFACTURER REPORT #3002808486-2016-00082, WILL BE CLOSED/CANCELLED AS THE PATIENT HAD THE FILTER SUCCESSFULLY RETRIEVED, AND DID NOT HAVE ANY ADVERSE EVENT OR INJURY DURING THE IMPLANT PERIOD OR FILTER RETRIEVAL. MANUFACTURER REFERENCE (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT 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.
(B)(4). LOT #: UNKNOWN AS INFORMATION WAS NOT PROVIDED. 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, K090140, K112119, K121057 OR K121629. MFR DATE IS UNKNOWN AS LOT # IS UNKNOWN. INVESTIGATION IS STILL IN PROGRESS.
DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2013". PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2013 AT (B)(6) MEDICAL CENTER, (B)(6)." 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 |
|---|---|---|---|---|---|---|---|
| 126282 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |