inforMED
InjuryITO

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

Model number

CAREMAX DPRL

Catalog 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.