HANDY SOLUTIONS

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

PATIENT USING HANDY SOLUTION HEATING PAD WHEN IT CAUGHT FIRE. PATIENT STATES IT WAS ONLY THE 2ND USE ON A NEW HEATING PAD. SHE STATES SHE SMELLED SMOKE/BURNING PLASTIC BEFORE SHE HEARD THE SMOKE DETECTOR OR FELT ANY PAIN DUE TO HER NEUROPATHY. MEMBER REPORTS REDNESS AND PAIN ON THE SKIN IN THE AREA WHERE THE HEATING PAD HAD BEEN.SHE REPORTS NO BLISTERS OR DEEPER BURNS, SHE USED ALOE AND THE AREA HEALED IN A FEW WEEKS. PATIENT HAS NEUROPATHY POTENTIALLY CAUSINGHER NOT TO FEEL THE OVERHEATING OF THE HEATING PAD BEFORE IT CAUGHT FIRE.