inforMED
InjuryIME

INSTANT COLD THERAPY WRAP

Received Jul 8, 2016

Report 3005182235-2016-00013 · MDR key 5779125

Device

Generic name

Instant Cold Therapy Wrap

Model number

TMF0362277

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Partial thickness (Second Degree) Burn
  • Partial thickness (Second Degree) Burn

Narrative

Description of Event or Problem

A COMPLAINT WAS RECEIVED REGARDING THE INSTANT COLD THERAPY WRAP - WHEN THE END-USER USED IT ON HER SHOULDER, HER SKIN BEGAN TO BURN AS IF IT WAS ACID. THE END-USER HAD SEVERAL BLISTERS GOING AROUND HER SHOULDER.