HOT/COLD PACK

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE DEVICE WAS PLACED IN THE MICROWAVE AND HEATED FOR 45 SECONDS. UPON COMPLETION OF THE 45 SECONDS, THE TURNTABLE STOPPED AND THE END USER OPENED THE DOOR OF THE MICROWAVE. SHE STATES THAT WHEN SHE DID, THE PACK EXPLODED, SENDING THE CONTENTS ON HER FACE, NECK AND ARM. SHE WAS SEEN BY HER PHYSICIAN AND WAS DIAGNOSED WITH FIRST AND SECOND DEGREE BURNS. A TOPICAL STEROID AND TOPICAL ANTIBIOTIC WERE PRESCRIBED. NAPROXEN AND TYLENOL WERE ALSO PRESCRIBED FOR THE PAIN. THE END USER STATES THE PACK LEAKED FROM ONE OF THE SEAMS. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. WE HAVE NO PHOTOS. A ROOT CAUSE HAS NOT BEEN DETERMINED.

Description of Event or Problem

THE END USER WAS BURNED BY THE CONTENTS OF THE HOT PACK.