InjuryIME
SMARTTEMP
Received Nov 25, 2015 · Event occurred Oct 29, 2015
Report 1314800-2015-00077 · MDR key 5276830
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
THE CONSUMER REPORTED USING THE HOT/COLD PACK AS A COLD PACK AND RECEIVED TWO BLISTERS AFTER USING THE PRODUCT ON HER KNEE. SHE STATED THAT SHE WAS GOING TO BE SEEKING MEDICAL ATTENTION FOR THIS INCIDENT. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.