FDA Adverse Event
Death
Summary report: N
HEM-O-LOK
MDR report key: 585466
·
Received March 28, 2005
Report
- Report Number
- 1044475-2005-00007
- Event Type
- Death
- Date Received
- March 28, 2005
- Date of Event
- February 1, 2005
- Report Date
- March 28, 2005
- Manufacturer
- WECK, TELEFLEX MEDICAL
- Product Code
- FZP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE WECK SALES REPRESENTATIVE NOTIFIED WECK, TELEFLEX MEDICAL IN 2005. THE INITIAL REPORT STATED THAT A DONOR, DIED A FEW HOURS AFTER A LIVE DONOR NEPHRECTOMY. THE EVENT OCCURRED AT THE NATIONAL UNIVERSITY HOSPITAL.
Description of Event or Problem · 1
NO CHANGES FROM ORIGINAL SUBMISSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEM-O-LOK | POLYMER LIGATION CLIP | FZP | WECK, TELEFLEX MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Death |