FDA Adverse Event
Injury
Summary report: N
ZIMMER DERMATOME BLADE
MDR report key: 3960938
·
Received June 27, 2014
Report
- Report Number
- 1526350-2014-00384
- Event Type
- Injury
- Date Received
- June 27, 2014
- Date of Event
- May 21, 2014
- Report Date
- May 29, 2014
- Manufacturer
- ZIMMER SURGICAL
- Product Code
- GFD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- 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 ZIMMER DERMATOME BLADE WAS USED ON A PATIENT'S LEFT UPPER THIGH TO OBTAIN A SKIN GRAFT. THE FIRST ATTEMPT FOR THE GRAFT SHREDDED THE PATIENT'S SKIN AND THE SECOND GRAFT WAS ALSO UNSUCCESSFUL. THE PATIENT HAD A LARGER THAN EXPECTED LEFT UPPER THIGH WOUND FROM THE DERMATOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 375957 | ZIMMER DERMATOME BLADE | ZIMMER DERMATOME BLADE | GFD | ZIMMER SURGICAL | UNK | 62291908 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |