MalfunctionGFD
DERMATOME AN HANDPIECE
Received Jul 1, 2026
Report 0001526350-2026-00767 · MDR key 25684135
Device
Product problems
- Output below Specifications
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN - EVENT OCCURRED IN UNITED KINGDOM. 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 UNIT HAD NOT ENOUGH POWER, THAT THE UNIT COULD NOT TAKE THE SKIN GRAFT. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.