MalfunctionGFD
HANDPIECE, ELECTRIC DERMATOME
Received May 21, 2026
Report 0001526350-2026-00598 · MDR key 25249836
Device
Product problems
- Failure to Cut
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN - EVENT OCCURRED IN POLAND. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT DURING AN UNKNOWN TIME, THE GRAFT TEARS DURING SKIN GRAFTING. IT IS UNKNOWN WHAT THE PATIENT IMPACT WAS OR IF A DELAY OCCURRED. DUE DILIGENCE IS IN PROGRESS.