FDA Adverse Event
Malfunction
Summary report: N
SKIN GRAFT MESHER PLS 02
MDR report key: 5053282
·
Received September 3, 2015
Report
- Report Number
- 5053282
- Event Type
- Malfunction
- Date Received
- September 3, 2015
- Date of Event
- March 13, 2015
- Report Date
- March 13, 2015
- Product Code
- FZW
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
MESHER DID NOT WORK PROPERLY. SKIN IS STRINGY INSTEAD OF THE USUAL MESH PATTERN THE MESHER IS SUPPOSED TO CREATE; SKIN DID NOT STRETCH AS USUAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584171 | SKIN GRAFT MESHER PLS 02 | FZW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |