FDA Adverse Event
Malfunction
Summary report: N
ZIMMER AIR DERMATOME
MDR report key: 20598443
·
Received November 4, 2024
Report
- Report Number
- 0001526350-2024-01351
- Event Type
- Malfunction
- Date Received
- November 4, 2024
- Date of Event
- October 9, 2024
- Report Date
- December 9, 2024
- Manufacturer
- ZIMMER SURGICAL, INC.
- Product Code
- GFD
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS MDR IS A DUPLICATE OF 0001526350-2024-01527. THE INITIAL REPORT WAS CREATED IN ERROR AND SHOULD BE VOIDED.
Additional Manufacturer Narrative · 0
AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER CMP-0964192. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER.
Description of Event or Problem · 0
THIS MDR IS A DUPLICATE OF 0001526350-2024-01527. THE INITIAL REPORT WAS CREATED IN ERROR AND SHOULD BE VOIDED.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING SURGERY, THE AIR DERMATOME GOUGED A PATIENT AND RUINED SKIN ON A SKIN GRAFT PROCEDURE. THERE WAS NO SURGICAL DELAY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS IN PROGRESS, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 789587 | ZIMMER AIR DERMATOME | DERMATOME | GFD | ZIMMER SURGICAL, INC. | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose | UNK DERMATOME BLADELN: UNK |