InjuryIME
HOT COLD WRAP
Received May 4, 2015 · Event occurred Mar 31, 2015
Report 3005182235-2015-00003 · MDR key 4746584
Device
Generic name
Hot/cold Packs, Reusable
Manufacturer
Tops Medical Articles IndustryModel number
TPF201RBCatalog number
TPF201RB
Lot number
NOT AVAILABLE
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Full thickness (Third Degree) Burn
Narrative
Description of Event or Problem
HUSBAND PURCHASED THE TPF201RB FROM (B)(6). HEATED FOR 1 MINUTE IN A 1,000 WATT MICROWAVE. PUT DIRECTLY ON WIFE'S ANKLE FOR 10 - 15 MINUTES. WIFE HAS 3RD DEGREE BURNS. NO CIRCULATORY ISSUES. BRAIN DISEASE AND SHE CANNOT TALK ANYMORE.