FDA Adverse Event
Malfunction
Summary report: N
ZIMMER SKIN GRAFT MESHER
MDR report key: 2043359
·
Received February 25, 2011
Report
- Report Number
- 1526350-2011-00029
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- January 1, 2011
- Report Date
- January 28, 2011
- Manufacturer
- ZIMMER SURGICAL
- Product Code
- GFD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- 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 THE CUTTER WAS NOT CUTTING PROPERLY. 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 | GFD | ZIMMER SURGICAL | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |