InjuryIME
CAREX HOT/COLD WRAP
Received Jun 2, 2015
Report 2182780-2015-00007 · MDR key 4811389
Device
Manufacturer
Tops Medical Articles Industries (nantong) Inc.Model number
TPF302NHACatalog number
TPF302NHA
Product problems
- Overheating of Device
Patient
80 YR
- Full thickness (Third Degree) Burn
Narrative
Description of Event or Problem
ATTORNEY CALLED: ACCORDING TO END USER, HE READ DIRECTIONS (FOR HOT/COLD WRAP), PUT IT ON HIS LOG. HEATED FOR 1 MINUTE TO ESTABLISH COMFORTABLE TEMPERATURE. WAS NOT WARM ENOUGH, PUT BACK IN FOR 1.5 MINUTES. PUT ON HIS LEG FOR 10 MINUTES. TOOK IT OFF, NOTICED REDNESS, 4-5 SPOTS. SAW A PHYSICIAN'S ASSISTANT - TOLD HIM HE HAD 2ND DEGREE BURNS. WENT BACK TO PA AND WAS DIRECTED TO SEE A PHYSICIAN. PHYSICIAN INDICATED HE HAD 3RD DEGREE BURNS. HAS HAD HEALTH ISSUE WITH HIS LEGS. UNK IF HE HAS CIRCULATORY ISSUES.