FDA Adverse Event
Malfunction
Summary report: N
ZIMMER SKIN GRAFT MESHER
MDR report key: 3021256
·
Received March 21, 2013
Report
- Report Number
- 1526350-2013-00138
- Event Type
- Malfunction
- Date Received
- March 21, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 19, 2013
- Manufacturer
- ZIMMER SURGICAL
- Product Code
- FZW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER; 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 ZIMMER SKIN GRAFT MESHER WAS NOT PULLING THE GRAFT THROUGH THE MESHER. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 118463 | ZIMMER SKIN GRAFT MESHER | ZIMMER SKIN GRAFT MESHER | FZW | ZIMMER SURGICAL | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00-7703-015-00, 1.5:1 RATIO SN #(B)(4) |