BOTTLE,WATER,HOT/COLD THERAPY,2QT,4BX/CS

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE HOT/COLD THERAPY WATER BOTTLE BURST DURING USE AND HOT WATER ENTERED THE END-USER'S LEFT EAR. AT THE TIME OF THE INCIDENT, THE PRODUCT WAS BEING USED TO PROVIDE HOT THERAPY TO THE END-USER'S SHOULDER. AFTER THE REPORTED BURST, THE END-USER WENT TO A LOCAL HOSPITAL'S EMERGENCY DEPARTMENT (ED) WHERE HE WAS EXAMINED AND DIAGNOSED WITH A BURN TO HIS LEFT EAR DRUM. THE END-USER WAS DISCHARGED HOME FROM THE ED WITH A PRESCRIPTION FOR PERCOCET, A PRESCRIPTION FOR AN UNIDENTIFIED EAR DROP ANTIBIOTIC, AND FOLLOW-UP WITH AN OTORHINOLARYNGOLOGIST. THE HOT/COLD THERAPY WATER BOTTLE WAS DISCARDED AT THE TIME OF THE INCIDENT AND NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A ROOT CAUSE FOR THE REPORTED INCIDENT WAS UNABLE TO BE DETERMINED. DUE TO THE REPORTED BURN AND NEED FOR MEDICAL TREATMENT, 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 THE HOT/COLD THERAPY WATER BOTTLE BURST DURING USE AND HOT WATER ENTERED THE END-USER'S LEFT EAR.