HANDY SOLUTIONS

Description of Event or Problem

PATIENT CALLED TO REPORT RECEIVING LETTER ADVISING OF OVERHEATING ISSUE WITH HEATING PAD (OTC#448) PURCHASED FROM PHARMACY OTC DEPARTMENT. PATIENT STATES SHE USED THE HEATING PAD A FEW TIMES SINCE 2025. PATIENT STATES SHE LIVES IN, THEREFORE DOES NOT NEED TO USE HEATING PAD MUCH DUE TO WARM TEMPERATURES. PATIENT STATES SHE NOTICED BURN MARKS ON MATTRESS 3 TO 4 WEEKS AGO. PATIENT STATES SHE DID NOT REPORT IT BECAUSE SHE THOUGHT IT WAS A "FLUKE". PATIENT STATES SHE DECIDED TO REPORT INCIDENT, AFTER RECEIVING LETTER NOTIFYING HER OF AN OVERHEATING DEFECT OF THE PAD EXPLAINED IN THE LETTER FROM. PATIENT REQUESTING REPLACEMENT OF HER MATTRESS. PATIENT DID NOT SUFFER ANY PERMANENT BODILY INJURY. PATIENT STATES SHE STILL HAS THE MATTRESS AND 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: ZX260209-C060401) AND NO DEFECTS IDENTIFIED.