UNKNOWN
Report
- Report Number
- 3002808486-2015-00159
- Event Type
- Injury
- Date Received
- November 19, 2015
- Report Date
- November 10, 2015
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
THIS EVENT HAS ALSO BEEN SUBMITTED TO FDA UNDER MANUFACTURER REPORT #3002808486-2014-00001. ALL FUTURE MEDWATCH REPORTS CONCERNING THIS EVENT WILL BE REFERRED TO IN MANUFACTURER REPORT #3002808486-2014-00001. MANUFACTURER REPORT#3002808486-2015-00159 WILL BE CLOSED/CANCELLED, AS THIS IS A DUPLICATE REPORT. (B)(4). CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS A COOK CELECT FILTER. AS CATALOG# IS UNKNOWN IT COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. (B)(4). 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# IS UNKNOWN IT COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. INVESTIGATION IS STILL IN PROGRESS.
DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] WAS IMPLANTED WITH A COOK CELECT FILTER ON (B)(6) 2013". PATIENT OUTCOME: IT IS ALLEGED THAT PATIENT 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] WAS IMPLANTED WITH A COOK CELECT FILTER ON (B)(6) 2013 AT (B)(6)." PATIENT OUTCOME: IT IS ALLEGED THAT PATIENT 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 |
|---|---|---|---|---|---|---|---|
| 767705 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |