InjuryIMG
CHATTANOOGA
Received Aug 29, 2025 · Event occurred May 29, 2025
Report 9616086-2025-00060 · MDR key 22929617
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
62 YR · Male
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE E-STIM THERAPY IS BURNING PATIENTS, PATIENT SUSTAINED A DIME SIZED 2ND DEGREE BURN UNDER ONE ELECTRODE.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE E-STIM THERAPY IS BURNING PATIENTS, PATIENT SUSTAINED A DIME SIZED 2ND DEGREE BURN UNDER ONE ELECTRODE. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, THE ROOT CAUSE COULD NOT BE ESTABLISHED. IF MORE INFORMATION BECOMES AVAILABLE ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT.