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 RECEIVED AN OVER THE COUNTER HEATING PAD THAT LATER WAS RECALLED. PATIENT STATES THE HEATING PAD FELT VERY HOT ON HER NECK WHILE IN USE. PATIENT LEFT HEATING PAD ON HER CHAIR/RECLINER WHILE USING THE RESTROOM. WHEN PATIENT RETURNED,THE HEATING PAD HAD MELTED THE CHAIR.