FDA Adverse Event
Malfunction
Summary report: N
ZIMMER SKIN GRAFT MESHER
MDR report key: 2505266
·
Received March 21, 2012
Report
- Report Number
- 1526350-2012-00051
- Event Type
- Malfunction
- Date Received
- March 21, 2012
- Date of Event
- February 1, 2012
- Report Date
- February 20, 2012
- Manufacturer
- ZIMMER SURGICAL
- Product Code
- FZW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MFR; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE USING THE ZIMMER SKIN GRAFT MESHER THE GRAFT WAS CAUGHT IN GUARD. THE GRAFT BOARD PASSED EASILY THROUGH BUT THE GRAFT DID NOT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER SKIN GRAFT MESHER | ZIMMER SKIN GRAFT MESHER | FZW | ZIMMER SURGICAL | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |