HANDY SOLUTIONS NECK AND SHOULDERS HEATING PAD

Additional Manufacturer Narrative

RECEIVED MW5186233 VIA EMAIL.

Description of Event or Problem

PATIENT CALLED TO REPORT RECEIVING LETTER ADVISING OF OVERHEATING ISSUE WITH HEATING PAD (OTC # 448) PURCHASED FROM (B)(6) PHARMACY OTC DEPARTMENT. PATIENT STATES SHE USED THE HEATING PAD A FEW TIMES SINCE (B)(6) 2025. PATIENT STATES SHE LIVES IN (B)(6) THEREFORE DOES NOT NEED TO USE HEATING PAD MUCH DUE TO (B)(6) 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 (B)(6). PATIENT REQUESTING REPLACEMENT OF HER MATTRESS. PATIENT DID NOT SUFFER ANY PERMANENT BODILY INJURY. PATIENT STATES SHE STILL HAS THE MATTRESS AND HEATING PAD.