CHATTANOOGA
Received Dec 8, 2025 · Event occurred Nov 10, 2025
Report 9616086-2025-00072 · MDR key 23737952
Device
Product problems
- Temperature Problem
- Temperature Problem
Patient
NA · Female
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
CUSTOMER REPORTS INJURY TO CUSTOMER, CUSTOMER REPORTED FRICTION TYPE BURNS ON HER RIGHT-SIDE MID BACK DAYS AFTER TREATMENT WITH RPW2 2176KIT SN (B)(6). CUSTOMER REPORTS NO ANOMALIES WITH UNIT, NO MEDICAL TREATMENT RENDERED.
Additional Manufacturer Narrative
CUSTOMER REPORTS INJURY TO CUSTOMER, CUSTOMER REPORTED FRICTION TYPE BURNS ON HER RIGHT-SIDE MID BACK DAYS AFTER TREATMENT WITH RPW2 2176KIT SN (B)(6). CUSTOMER REPORTS NO ANOMALIES WITH UNIT, NO MEDICAL TREATMENT RENDERED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, THE ROOT CAUSE COULD NOT BE CONFIRMED ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF MORE INFORMATION BECOMES AVAILABLE.