FDA Adverse Event
Injury
Summary report: N
WECK HEM-O-LOK CLIPS, LARGE
MDR report key: 1960931
·
Received January 10, 2011
Report
- Report Number
- 3003898360-2011-00005
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- November 16, 2010
- Report Date
- December 14, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- FZP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
UNK IF SAMPLE AVAILABLE FOR INVESTIGATION. INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: DURING A RENAL ARTERY LIGATION, 2 CLIPS DID NOT LOCK ON THE ARTERY RESULTING IN AN ACTIVE HEMORRHAGE. THIS REQUIRED MEDICAL INTERVENTION. THE CLIPS WERE RECOVERED FROM A HEMATOMA ON THE ARTERY. ADD'L INFO REGARDING THE PT'S CONDITION AND AVAILABILITY OF SAMPLE WAS REQUESTED, BUT NOT RECEIVED YET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WECK HEM-O-LOK CLIPS, LARGE | HEM-O-LOK CLIPS | FZP | TELEFLEX MEDICAL | NA | 01E0900185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R |