THERMAL-MAX HEAT PACK

Description of Event or Problem

PATIENT'S ATTORNEY STATED DEVICE "EXPLODED" IN MICROWAVE WHEN PATIENT RETRIEVED THE DEVICE. MADE A LOUD SOUND WHEN EXPLODING. HEATED LIQUID INSIDE DEVICE CONTACTED PATIENT, INCLUDING THROUGH CLOTHING, CAUSING 2ND DEGREE BURNS ON TORSO, HANDS, AND FACE. ATTORNEY DID NOT KNOW HOW LONG PATIENT HEATED THE DEVICE IN MICROWAVE. PATIENT HAS USED THE PRODUCT MULTIPLE TIMES BEFORE. ATTORNEY CONFIRMED THE HEATING PAD WAS IN THE COMFORT WRAP WHEN THE INCIDENT OCCURRED.

Additional Manufacturer Narrative

LIFE WEAR'S ABILITY TO INVESTIGATE THIS INCIDENT HAS BEEN LIMITED BY A LACK OF INFORMATION FROM THE PATIENT AND THE INABILITY TO INSPECT THE DEVICE THAT WAS INVOLVED IN THE INCIDENT. LIFE WEAR HAS CONDUCTED ADDITIONAL TESTING ON RETAINED DEVICES, INCLUDING REJECTED DEFECTIVE DEVICES THAT REPRESENT A "WORST CASE" SCENARIO, AND HAS BEEN UNABLE TO DUPLICATE THE REPORTED RESULT (I.E., RUPTURE OF THE DEVICE) WITHOUT SIGNIFICANTLY EXCEEDING THE HEATING INSTRUCTIONS STATED IN THE DEVICE LABELING. A REVIEW OF PRODUCTION RECORDS AND COMPLAINT FILES DOES NOT SUGGEST ANY TREND ASSOCIATED WITH THIS TYPE OF EVENT. LIFE WEAR HAS NOT RECEIVED ANY COMPLAINTS OF SIMILAR TYPES OF FAILURES OR INJURIES.