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