HANDY SOLUTIONS
Received Mar 4, 2026 · Event occurred Jan 22, 2026
Report 3030539818-2026-00003 · MDR key 24511488
Device
Product problems
- Overheating of Device
Patient
50 YR · Unknown
- Insufficient Information
Narrative
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
USER STATES THE SECOND TIME SHE USED IT, SOMETHING SMELLED HOT. DID NOT STATE IT CAUGHT ON FIRE, BUT SHE DID STATE HER BACK WAS BURNED AND BLISTERED. WENT TO THE ER, GOING TO BURN AND WOUND PLASTIC SURGERY CENTER ON.