FDA Adverse Event
Injury
Summary report: N
HEM-O-LOK ML POLYMER CLIPS
MDR report key: 631814
·
Received August 29, 2005
Report
- Report Number
- 1044475-2005-00011
- Event Type
- Injury
- Date Received
- August 29, 2005
- Date of Event
- July 1, 2005
- Report Date
- August 29, 2005
- Manufacturer
- WECK, TELEFLEX MEDICAL
- Product Code
- FZP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PROCEDURE: LAPAROSCOPIC NEPHRECTOMY A LAPAROSCOPIC NEPHRECTOMY WAS PERFORMED ON A PT USING HEM-O-LOK ML POLYMER CLIPS. TWO HEM-O-LOK ML CLIPS WERE USED TO LIGATE THE RENAL ARTERY WITH A 1-2 MM CUFF. APPROX 3-4 HOURS POST-OP, THE PT EXPERIENCED A DROP IN BLOOD PRESSURE. THE PT WAS REOPENED AND SITE OF LIGATION WAS MISSING THE TWO CLIPS. SURGEON REPAIRED THE SITE BY SUTURE. PT REQUIRED 11 PINTS OF BLOOD TRANSFUSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEM-O-LOK ML POLYMER CLIPS | POLYMER LIGATION CLIPS | FZP | WECK, TELEFLEX MEDICAL | NA | 1997068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Life Threatening| R |