InjuryIME
SMARTTEMP
Received Dec 2, 2013 · Event occurred Nov 14, 2013
Report 1314800-2013-00048 · MDR key 3503286
Device
Product problems
- Leak/Splash
- Improper or Incorrect Procedure or Method
Patient
UNK
- Burn(s)
Narrative
Description of Event or Problem
THE CONSUMER REPORTED THE GEL PACK DEVELOPED A LEAK WHILE IN THE MICROWAVE. THE GEL LEAKED OUT AND CAUSED A BURN TO HIS ARM. THE CONSUMER DID SEEK MEDICAL ATTENTION FOR THE BURN BUT THERE WERE NO FURTHER COMPLICATIONS. WHEN THE GEL PACKS ARE MICROWAVED FOR TOO LONG THEY EXPAND AND CAN DEVELOP LEAKS ALONG THE SEAM. THE INSTRUCTIONS HAVE CLEARLY STATED HEATING TIMES TO PREVENT LEAKS.