GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2016-00093
- Event Type
- Injury
- Date Received
- March 9, 2016
- Report Date
- February 19, 2016
- Manufacturer
- COOK INC
- Product Code
- DTK
- PMA / PMN Number
- K090140
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- ATTORNEY
Narratives
(B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK GUNTHER TULIP FILTER. INVESTIGATION IS STILL IN PROGRESS.
ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC. WITH THE SUBMISSION OF THIS FOLLOW UP REPORT, WILLIAM COOK EUROPE INFORMS THAT THIS COMPLAINT HAS BEEN TRANSFERRED FROM WILLIAM COOK EUROPE TO COOK INC. COOK INC. WILL HANDLE THIS EVENT UNDER REFERENCE# 1820334-2016-01160 FOR ALL FUTURE REPORTS TO FDA. (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK GUNTHER TULIP FILTER. INVESTIGATION IS STILL IN PROGRESS.
DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT: IT IS ALLEGED THAT "[PT] RECEIVED A COOK GUNTHER TULIP FILTER ON (B)(6) 2009 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.
DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT: IT IS ALLEGED THAT "[PT] RECEIVED A COOK GUNTHER TULIP FILTER ON (B)(6) 2009". 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 |
|---|---|---|---|---|---|---|---|
| 144635 | GUNTHER TULIP JUGULAR VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | COOK INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| O |