ICE IT
Received Sep 23, 2014 · Event occurred Aug 18, 2014
Report 1811605-2014-00194 · MDR key 4206860
Device
Product problems
- Use of Device Problem
- Improper or Incorrect Procedure or Method
- Temperature Problem
Patient
Not reported
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
PURCHASED FROM A PHARMACY. THE ICE PACK WAS FROZEN SOLID AND SHE DIDN'T KNOW IT WASN'T SUPPOSE TO BE USED ONLY ONE IN THE SHOULDER SYSTEM, ALSO BOUGHT A KNEE ONE 512 AND THEY ARE FROZEN SOLID. RECEIVED A SERVER BURN. IT IS GETTING BETTER BUT STILL HAS BLISTERS.
Additional Manufacturer Narrative
THE DESCRIPTION OF USE BY THE USER IS IN DIRECT CONFLICT WITH THE INSTRUCTIONS FOR USE. THE ICE PACKS SHOULD NOT BE USED IN DIRECT CONTACT WITH THE USER. A HOLSTER IS PROVIDED TO CREATE AN INSULATION BARRIER BETWEEN THE ICE PACK AND TISSUE. TESTING ON THE RETURNED ICE PACKS SHOW THAT THEY REMAINED FLEXIBLE AFTER 4 DAYS IN AN 8F FREEZER. TYPICALLY, THESE ICE PACKS WILL REMAIN FLEXIBLE TO TEMPERATURES NEAR 0F. BASED ON THIS INFORMATION, WE CONCLUDED THAT THE FROSTBITE WAS A RESULT OF IMPROPER APPLICATION THE PRODUCT BY THE USER THAT WAS STORED AT A TEMPERATURE NEAR 0F.