FDA Adverse Event
Injury
Summary report: N
HEM-O-LOK L LIGATION CLIPS
MDR report key: 640734
·
Received October 14, 2005
Report
- Report Number
- 1044475-2005-00014
- Event Type
- Injury
- Date Received
- October 14, 2005
- Date of Event
- September 1, 2005
- Report Date
- October 14, 2005
- Manufacturer
- WECK, TELEFLEX MEDICAL
- Product Code
- FZP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WECK, TELEFLEX MEDICAL RECEIVED NOTICE THAT A PT WAS REQUIRED TO BE REOPENED AFTER A LAPAROSCOPIC DONOR NEPHRECTOMY. AFTER RE-OPENING THE PT, IT WAS OBSERVED THAT THE TWO HEM O-LOK CLIPS USED TO LIGATE THE ARTERIAL SIDE OF THE PT WAS NO LONGER ON THE LIGATION SITE. THE ARTERIAL CUFF WAS RE LIGATED AND THE PT IS RECOVERING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEM-O-LOK L LIGATION CLIPS | LARGE POLYMAR LIGATION CLIP | FZP | WECK, TELEFLEX MEDICAL | NA | 1997099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Life Threatening| R |