inforMED
InjuryIME

INSTANT COOLING THERAPY WRAP

Received Aug 2, 2016 · Event occurred Jul 11, 2016

Report 3005182235-2016-00021 · MDR key 5841603

Device

Generic name

Cooling 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

  • Burn(s)
  • Burn(s)

Narrative

Description of Event or Problem

THE END-USER'S SKIN WAS VERY BADLY BURNED AND IN PAIN FROM USE WITH THE COOLING THERAPY WRAP. THE USER HAD ONLY USED THE WRAP ONE TIME WHEN THIS EVENT HAD OCCURRED. THE USER REPORTS THAT WHEN HE/SHE OPENED THE PACKAGE, THE PRODUCT HAD A STRONG ODOR, BUT HE/SHE HAD ASSUMED THIS WAS NORMAL - UNIT REMOVING THE WARP AND SEEING HOW BADLY HIS/HER SKIN WAS BURNED. HE/SHE DOESN'T KNOW IF HE/SHE GOT A DEFECTIVE ITEM OR WHY THIS HAD HAPPENED.