FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 5719734
·
Received June 13, 2016
Report
- Report Number
- 3002808486-2016-00500
- Event Type
- Injury
- Date Received
- June 13, 2016
- Report Date
- June 3, 2016
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CATALOG NUMBER UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS EITHER GUNTHER TULIP MREYE, GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER OR COOK CELECT PLATINUM. SINCE CATALOG NUMBER IS UNKNOWN THE 510(K) COULD BE EITHER K000855, K032426, K061815, K073374, K090140, K112119, K121057 OR K121629. INVESTIGATION IS STILL IN PROGRESS.
Description of Event or Problem · 1
DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK IVC FILTER." 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 |
|---|---|---|---|---|---|---|---|
| 375915 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |