inforMED
InjuryIME

INSTANT COLD THERAPY WRAP

Received Jul 6, 2016 · Event occurred Mar 20, 2016

Report 3005182235-2016-00010 · MDR key 5773643

Device

Generic name

Instant Cold Therapy Wrap

Model number

TMF0362277

Product problems

  • Physical Property Issue
  • Physical Property Issue

Patient

25 YR

  • Burn(s)
  • Burn, Thermal
  • Burn(s)
  • Burn, Thermal

Narrative

Description of Event or Problem

ON (B)(6) 2016, AT 3:14PM, THE CUSTOMER/END-USER PURCHASED AN INSTANT COOLING THERAPY WRAP. AT 3:35PM, ON SAID DATE, THE END-USER APPLIED THE THERAPY WRAP TO HER RIGHT KNEE, WHICH WAS EXPERIENCING SORENESS FROM A PRIOR STRAIN. SHORTLY THEREAFTER, THE END-USER SUFFERED SEVERE BURNS FROM THE WRAP, AND SHE REMOVED IT FROM HER LEG. IT IS HEREIN ALLEGED THAT THE INSTANT COOLING THERAPY WRAP PURCHASED BY THE END-USER WAS DEFECTIVE IN THAT IT CAUSED SEVERE BURNS TO HER RIGHT KNEE AND RIGHT LEG. THE BURNS RUPTURED HER SKIN, AND ARE EXPECTED TO LEAD TO PERMANENT SCARRING, DISFIGUREMENT AND POTENTIAL LOSS OF FUNCTION.