DONJOY
Received Jul 6, 2026 · Event occurred Apr 4, 2026
Report 9616086-2026-00025 · MDR key 25727431
Device
Product problems
- Patient Device Interaction Problem
Patient
NA · Unknown
- Burn(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT SUSTAINED A COLD BURN WHILE USING THE ICEMAN UNIT, SEVERITY OF THE BURN INJURY IS UNKNOWN.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PATIENT SUSTAINED A COLD BURN INJURY FROM THE PAD WHILE USING THE ICEMAN UNIT. THE DEVICE WAS NOT RETURNED FOR EVALUATION; PHOTOS OF THE INJURY WERE ALSO NOT PROVIDED, IT IS INKNOWN IF MEDICAL TREATMENT WAS PROVIDED TO THE PATIENT. THE ROOT CAUSE COULD NOT BE ESTABLISHED AT THIS TIME. IF ADDITIONAL INFORMATION ON THIS REPORTED EVENT BECOMES AVAILABLE THIS INVESTIGATION WILL BE REEVALUATED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.