UNKNOWN
Report
- Report Number
- 3002808486-2015-00172
- Event Type
- Injury
- Date Received
- December 15, 2015
- Report Date
- November 21, 2015
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- ATTORNEY
Narratives
THIS EVENT HAS ALSO BEEN SUBMITTED TO FDA UNDER MANUFACTURER REPORT # 3002808486-2016-00137. ALL FUTURE MEDWATCH REPORTS CONCERNING THIS EVENT WILL BE REFERED TO MANUFACTURER REPORT # 3002808486-2016-00137 AND MANUFACTURER REPORT # 3002808486-2015-00172 WILL BE CLOSED/CANCELLED. (B)(4). CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS A COOK CELECT FILTER. LOT# IS UNKNOWN AS INFORMATION WAS NOT PROVIDED. EXPIRATION DATE UNKNOWN AS LOT# IS UNKNOWN. AS CATALOG # IS UNKNOWN IT COULD BE EITHER K061815, K073374 OR K090140. INVESTIGATION IS STILL IN PROGRESS.
(B)(4). CATALOG NUMBER UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS A COOK CELECT FILTER. AS CATALOG NUMBER IS UNKNOWN IT COULD BE EITHER K061815, K073374 OR K090140. 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) 2010 AT THE (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.
DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2010 AT (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 |
|---|---|---|---|---|---|---|---|
| 825660 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |