FDA Adverse Event
Malfunction
Summary report: N
AIR DERMATOME HANDPIECE
MDR report key: 3853608
·
Received April 3, 2014
Report
- Report Number
- 1526350-2014-00251
- Event Type
- Malfunction
- Date Received
- April 3, 2014
- Date of Event
- June 21, 2013
- Report Date
- March 7, 2014
- Manufacturer
- ZIMMER SURGICAL
- Product Code
- GFD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE AIR DERMATOME HANDPIECE WAS FOUND TO HAVE TAKEN A DEEPER SPLIT SKIN GRAFT THAT EXPECTED FOR THE SETTINGS USED. THE REPORT STATES THAT THERE WAS NOTHING MECHANICALLY WRONG WITH THE DERMATOME. HOWEVER, AFTER INSPECTION ONE OF THE BLADE GUARDS EXHIBITED GOUGE MARKS ON THE FRONT OF THE PLATE WHERE THE SPIGOT HAD BEEN RUBBING. NO ADD'L CLINICAL INFO WAS RECEIVED PRIOR TO THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203485 | AIR DERMATOME HANDPIECE | AIR DERMATOME HANDPIECE | GFD | ZIMMER SURGICAL | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |