CAREMAX
Received Mar 6, 2013 · Event occurred Feb 18, 2013
Report 1528424-2013-00001 · MDR key 2999775
Device
Generic name
Caremax Dprl, Heated Care Brace
Manufacturer
Weigi InternationalModel number
CAREMAX DPRLCatalog number
A5144
Lot number
NA
Product problems
- Device Operates Differently Than Expected
Patient
74 YR
- Full thickness (Third Degree) Burn
Narrative
Description of Event or Problem
RN'S WIFE CONTACTED CUSTOMER SERVICE ON (B)(6) 2013 TO REPORT THAT SHE WANTED TO RETURN THE CARE MAX DPRL AND THAT HER HUSBAND HAD REC'D A BURN FROM THE PRODUCT. AT THAT TIME SHE INDICATED THAT SHE WOULD PROBABLY TAKE HIM TO SEE A DOCTOR. A F/U CONVERSATION WAS HELD WITH RN AND HIS WIFE ON (B)(4) 2013. (B)(6) REPORTED THAT RN HAD VISITED A DOCTOR AND WAS TREATED FOR A 3RD DEGREE BURN APPROX THE SIZE OF A HALF DOLLAR ON HIS SHOULDER. RN IS AN AMPUTEE AND WAS UNSUCCESSFUL AT PUTTING THE DEVICE ON HIS STUMP PROPERLY BECAUSE HE ONLY HAS ONE HAND. HE DID NOT PUT THE PROTECTIVE CLOTH UNDER THE UNIT IN ORDER TO PROTECT HIS SKIN. RN HAS NO FEELING IN HIS STUMP AND WAS UNABLE TO FEEL THE UNIT BURNING HIS SKIN. HE STATED THAT HE WASN'T SURE HOW LONG HE USED THE UNIT, BUT THAT IT WAS LESS THAN 25 MINS. THE DOCTOR TREATED THE WOUND WITH ANTIBIOTICS, CREAM AND UV TREATMENT LIGHT. (B)(6) FEELS THE WOUND IS HEALING NICELY.