FDA Adverse Event
Malfunction
Summary report: N
WECK HEM-O-LOK CLIPS ML
MDR report key: 2020586
·
Received February 10, 2011
Report
- Report Number
- 3003898360-2011-00023
- Event Type
- Malfunction
- Date Received
- February 10, 2011
- Report Date
- January 19, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- FZP
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
UNKNOWN IF SAMPLE IS AVAILABLE FOR INVESTIGATION. PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THIS EVENT IS REPORTED AS: DURING APPLICATION OF THE CLIPS, ONE CLIP OUT OF 6 STAYED LOCKED. OTHER CLIPS FROM THE SAME LOT# WERE USED SUCCESSFULLY. NO PATIENT INJURY OR CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WECK HEM-O-LOK CLIPS ML | HEM-O-LOK CLIPS | FZP | TELEFLEX MEDICAL | NA | 0D0900348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |