UNKNOWN
Report
- Report Number
- 3002808486-2016-00556
- Event Type
- Injury
- Date Received
- June 17, 2016
- Report Date
- May 27, 2016
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- ATTORNEY
Narratives
THIS EVENT HAS ALSO BEEN SUBMITTED TO FDA UNDER MANUFACTURER REPORT #3002808486-2016-00555, MANUFACTURER REPORT#3002808486-2016-00556 AND MANUFACTURER REPORT#3002808486-2016-00557. MANUFACTURER REPORT#3002808486-2016-00556 WILL BE CLOSED/CANCELLED, AS PATIENT DID NOT RECEIVE A FILTER MANUFACTURED BY COOK MEDICAL. (B)(4). CATALOG NUMBER: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. SINCE CATALOG NUMBER IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121629, K121057. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
(B)(4). SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121629, K121057. INVESTIGATION IS STILL IN PROGRESS.
DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT [PT] RECEIVED A FILTER ON (B)(6) 2012. 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 FILTER ON (B)(6) 2012 AT (B)(6) HOSPITAL, (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 |
|---|---|---|---|---|---|---|---|
| 388041 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |