InjuryIMI
CHATTANOOGA
Received May 23, 2025 · Event occurred Apr 21, 2025
Report 9616086-2025-00052 · MDR key 22081462
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT SUSTAINED A 3RD DEGREE BURN AFTER RECEIVING A 15 MINUTE TENS TREATMENT.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PATIENT SUSTAINED A 3RD DEGREE BURN AFTER RECEIVING A 15 MINUTE TENS TREATMENT. 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.