HANDY SOLUTIONS NECK AND SHOULDER HEATING PAD

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. THIRD PART TESTING REPORT (B)(4).

Description of Event or Problem

HEATING PAD OVERHEATED CAUSING BURNS/DAMAGE TO PROPERTY BUT PATIENT WAS NOT HARMED.