MalfunctionGFD
UNKNOWN DERMATOME
Received Jun 10, 2026
Report 0001526350-2026-00646 · MDR key 25458419
Device
Product problems
- Failure to Cut
Patient
NA · Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER (B)(4). 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
IT WAS REPORTED THAT DURING AN UNKNOWN TIME, THE UNIT WAS SHREDDING THE PATIENT'S SKIN. IT IS UNKNOWN WHETHER THERE WAS ANY PATIENT IMPACT OR DELAY. DUE DILIGENCE IS IN PROCESS; NO FURTHER INFORMATION IS AVAILABLE.