MalfunctionGFD
HANDPIECE, ELECTRIC DERMATOME
Received Jun 3, 2026
Report 0001526350-2026-00631 · MDR key 25374118
Device
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN - EVENT OCCURRED IN UNITED KINGDOM. (B)(6). THE DEVICE WILL BE RETURNED FOR ANALYSIS, 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 ON UNKNOWN DATE THE DEVICE POWER BUTTON FELL OFF. IT IS UNKNOWN IF THERE WAS PATIENT IMPACT. DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS NOTED.