HANDY SOLUTIONS
Received Apr 22, 2026 · Event occurred Feb 1, 2026
Report 3030539818-2026-00009 · MDR key 24949283
Device
Product problems
- Temperature Problem
Patient
71 YR · Female
- Insufficient Information
Narrative
Description of Event or Problem
MATERIAL HAD A SMALL HOLE. BEFORE USING IT THERE WAS SOME ORANGE THINGS ON THE MATERIAL. SHE STARTED USING IT, SMELLED SMOKE, TOOK IT OFF, LOOKED AT IT AND THEN THERE WAS A HOLE AND WIRES WERE EXPOSED. SHE DID NOT GET BURNED.
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)