FDA Adverse Event
Malfunction
Summary report: N
AIR DERMATOME HANDPIECE
MDR report key: 3040331
·
Received April 3, 2013
Report
- Report Number
- 1526350-2013-00161
- Event Type
- Malfunction
- Date Received
- April 3, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 4, 2013
- Manufacturer
- ZIMMER SURGICAL
- Product Code
- GFD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT BEING RETURNED TO THE MFR FOR ANALYSIS. IF ANY ADDITIONAL INFO IS RECEIVED, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME HAD A DAMAGED/LEAKING HOSE. THE INCIDENT WAS NOTED PRIOR TO PT USE, DURING STERILE PROCESSING. THERE WAS NO PT INJURY OR MEDICAL/SURGICAL INTERVENTION ASSOCIATED WITH THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136891 | AIR DERMATOME HANDPIECE | AIR DERMATOME HANDPIECE | GFD | ZIMMER SURGICAL | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |