InjuryIMG
CHATTANOOGA
Received Apr 25, 2025 · Event occurred Apr 1, 2025
Report 9616086-2025-00043 · MDR key 21915074
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT PATIENT SUSTAINED 2ND DEGREE BURNS UNDER 3 ELECTRODES DURING TREATMENT THAT REQUIRED MEDICAL TREATMENT AT URGENT CARE THE DEVICE HAS BEEN RETURNED AND EVALUATED. THE DEVICE PASSED ALL FUNCTIONAL TESTING AND IS IN GOOD SHAPE. LEAD WIRES WERE TESTED AND SHOW GOOD CONTINUITY. THE ROOT CAUSE NOT PROPERLY PREPARING SKIN OR USING OFF BRAND ACCESSORIES COULD CAUSE BURNS UNDER STIM THERAPY.
Description of Event or Problem
IT WAS REPORTED THAT PATIENT SUSTAINED 2ND DEGREE BURNS UNDER 3 ELECTRODES DURING TREATMENT THAT REQUIRED MEDICAL TREATMENT AT URGENT CARE.