HANDY SOLUTIONS NECK AND SHOULDERS HEATING PAD

Additional Manufacturer Narrative

IN REFERENCE TO MW5188259 RECEIVED VIA EMAIL FROM FDA.

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 (B)(6) 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 BEDSHEET. SHE THEN DISCARDED OF THE HEATING PAD AND DID NOT REPORT ANY INJURIES.