FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 5719730
·
Received June 13, 2016
Report
- Report Number
- 3002808486-2016-00503
- 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
MANUFACTURER REF# (B)(4). CATALOG # 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# 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 |
|---|---|---|---|---|---|---|---|
| 376262 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |