InjuryIME
N/A
Received Sep 19, 2016 · Event occurred Aug 31, 2016
Report 3005182235-2016-00031 · MDR key 5960855
Device
Product problems
- Physical Property Issue
- Temperature Problem
- Physical Property Issue
- Temperature Problem
Patient
Not reported
- Partial thickness (Second Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
CUSTOMER HAS HAD A HOT/COLD PACK FOR A COUPLE OF YEARS, AND HEATED IT FOR 1-1 1/2 MINUTES. HE THEN APPLIED IT TO HIS SHOULDER FOR 10 MINUTES. WHEN HE REMOVED IT, HE NOTICED IT TURNING RED. HE WENT TO THE EMERGENCY ROOM, WHERE HE WAS DIAGNOSED WITH 2ND DEGREE BURNS. THE END-USER REPORTED THAT HE HAD A CLOTH BARRIER BETWEEN HIS SKIN AND THE PACK. THERE ALSO WAS NOT ANY TOPICAL PAIN RELIEF MEDICATION REPORTED AS BEING ON THE SKIN PRIOR TO THE PACK APPLICATION.