NECK AND SHOULDERS 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.

Description of Event or Problem

PATIENT DOES NOT RECALL EXACT DATE BUT REPORTS TAKING THIS HEATING PAD OUT OF THE BOX AROUND WHEN IT WAS DELIVERED TO HER ON 2025, PLUGGING IT INTO AN ELECTRICAL OUTLET AND LEAVING IT ON HER BED. SHE LEFT THE ROOM AND UPON RETURNING TO THE ROOM SHE NOTICED THAT IT WAS SMOKING AND HER IT HAD BURNED A HOLE IN HER BED SHEET. SHE THEN DISCARDED OF THE HEATING PAD AND DID NOT REPORT ANY INJURIES.