BONE GROWTH STIMULATOR
Received May 8, 2025 · Event occurred Apr 22, 2025
Report 2183449-2025-00017 · MDR key 21987456
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
76 YR · Male
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
DEVICE HAS NOT RETURNED FOR INVESTIGATION. IF THE DEVICE IS RETURNED, WE WILL CONDUCT AN INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT STATED THE PATIENT WAS SHOCKED DURING TREATMENT BY THE DEVICE. IT WAS REPORTED THERE WAS A RED BURN MARK WHERE THE DEVICE SITS.
Description of Event or Problem
PATIENT REPORTED THEY WERE SHOCKED DURING TRATMENT BY THE DEVICE. IT WAS REPORTED THERE WAS A RED BURN MARK WHERE THE DEVICE SITS.
Additional Manufacturer Narrative
THE DEVICE RETURNED FOR INVESTIGATION. THERE IS NO NOTED SIGN OF DAMAGE TO POWER SUPPLY, DEVICE CONTROLLER OR FOAM COIL. WRAPPED THE DEVICE CONTROLLER ENCLOSURE, AND DEVICE FOAM COIL, AND PASSED ALL LEAKAGE CURRENT TESTING USING GW INSTEK (B)(4). DESIGN/MANUFACTURE MEETS SPEC. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL 56 UNITS IN THIS LOT PASSED INSPECTION AND WERE FUNCTIONING AS INTENDED. NO ANOMALIES FOUND.