InjuryIMI
CHATTANOOGA
Received Jul 13, 2024 · Event occurred Jun 13, 2024
Report 9616086-2024-00053 · MDR key 19736585
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT GETTING VERY HOT AND BURNED COUPLE OF OUR PATIENTS.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE DEVICE WAS GETTING VERY HOT AND BURNED A COUPLE OF PATIENTS. THE DEVICE WAS RETURNED AND EVALUATED; ERROR NOT DUPLICATED. THE US APPLICATOR WORKS FINE, NO PROBLEMS DETECTED. THE ROOT CAUSE COULD NOT BE ESTABLISHED.