FDA Adverse Event
Malfunction
Summary report: N
AIR DERMATOME HANDPIECE
MDR report key: 3101413
·
Received May 3, 2013
Report
- Report Number
- 1526350-2013-00226
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- April 1, 2013
- Report Date
- April 3, 2013
- Manufacturer
- ZIMMER SURGICAL
- Product Code
- GFD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER THE INVESTIGATION WAS 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 AIR DERMATOME WAS NOT POWERING ON. NO ADDITIONAL CLINICAL INFO WAS RECEIVED PRIOR TO THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194634 | AIR DERMATOME HANDPIECE | AIR DERMATOME HANDPIECE | GFD | ZIMMER SURGICAL | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |