HEATING PAD WRAP FOR SHOULDER AND NECK

Additional Manufacturer Narrative

THE MANUFACTURER RECEIVED A REPORT STATING THAT THE HEATING PAD OVERHEATED, ALONG WITH PHOTOS OF THE INCIDENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PRODUCT LABEL WARNED AGAINST USE ON SOFT SURFACE AND CAN'T BE COVERED DURING USE, YET THESE ACTIONS WERE OBSERVED IN THE INCIDENT PHOTOS. THIRD-PARTY TESTING CONFIRMED THE PRODUCT DOES NOT OVERHEAT UNDER CORRECT USE (SEE TEST REPORT: (B)(4) AND NO DEFECTS IDENTIFIED. FROM THE DESCRIBE EVENT, WE KNOW THE PATIENT FELL ASLEEP ON IT, THAT DIDN'T CONFORM TO THE CORRECT USAGE METHOD.

Description of Event or Problem

PATIENT USED NECK AND BACK HEATING PAD FROM NAVAJO MANUFACTURING COMPANY INC. PRODUCT WAS ITEM#: 448 FROM HUMANA OTC CATALOG HEATING PAD WRAP FOR SHOULDER AND NECK. PATIENT FELL ASLEEP ON IT AND WOKE UP TO THE SMELL OF FIRE. PATIENT'S PILLOW HAD A HOLE BURNED INTO IT AND PATIENT HAD A BURN ON HER NECK THAT BLISTERD. PATIENT STOPPED USE IMMEDIATELY.