InjuryIOR
CATALYST 5VX
Received Dec 20, 2022
Report 3005905321-2022-00004 · MDR key 16019479
Device
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
Unknown
- Partial thickness (Second Degree) Burn
- Full thickness (Third Degree) Burn
- Partial thickness (Second Degree) Burn
- Full thickness (Third Degree) Burn
Narrative
Description of Event or Problem
DEALER CALLED IN A COMPLAINT STATING THAT THE END USER HAD 2ND/3RD DEGREE BURNS ON SIDES AND BOTTOM OF FEET. END USER HAS/HAD VERY LITTLE FEELING IN FEET SO IT WAS NOT REALIZED UNTIL MUCH LATER. HAPPENED AFTER EXTENDED TIME IN THE SUN THIS PAST SUMMER.
Remedial action
- Modification/Adjustment
- Replace