PACK,HOT/COLD,REUSABLE,FAMLY DOLLR SKU

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE END-USER, WHO HAS HISTORY OF UNSPECIFIED CANCER AND HAS NEUROPATHY IN HER RIGHT ARM AND LEFT LEG, INITIATED USE OF COLD THERAPY AS INSTRUCTED BY HER PAIN DOCTOR. END-USER STATED SHE PUT THE COLD PACK IN THE FREEZER AND PULLED IT OUT THE NEXT DAY TO APPLY ON HER ARM. PER REPORT, THE END-USER PUT THE COLD PACK INTO A SOCK AND PUT THE PACK ON HER RIGHT ARM FOR APPROXIMATELY 10-12 MINUTES BEFORE SHE NOTICED THE AREA STARTED TO LOOKED RED AND FELT LIKE IT WAS BURNING. THERE WAS NO INTERVENTION PERFORMED AT THIS TIME. THE END-USER REPORTEDLY WENT TO HER PHARMACY TO PICK UP HER ROUTINE PRESCRIPTIONS AND AN EMPLOYEE AT THE PHARMACY TOLD HER THAT THERE WERE BLISTERS ON HER RIGHT ARM AND INSTRUCTED HER TO GO TO THE EMERGENCY ROOM FOR EVALUATION. IT WAS REPORTED THAT THE END-USER WENT TO THE EMERGENCY ROOM, WAS INFORMED THAT SHE HAD A SECOND DEGREE BURN AND WAS INSTRUCTED TO USE SULFADIAZINE 1% TO THE AFFECTED AREA FOR 5 DAYS AND COVER WITH GAUZE. SHORTLY AFTER THE EMERGENCY ROOM VISIT, END-USER HAD A REGULAR FOLLOW UP APPOINTMENT WITH HER DOCTOR AND WAS INSTRUCTED TO USE ALOE ON THE AREA. PER REPORT, THE AREA IS HEALING WELL AND END-USER CONTINUES TO USE ALOE TO HELP WITH HEALING. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. DUE TO THE REPORTED INCIDENT, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT END-USER HAD PARTIAL THICKNESS BURN OF THE RIGHT UPPER ARM FROM USING RE-USABLE COLD THERAPY BAG.