inforMED
InjuryIRT

HANDY SOLUTIONS

Received Mar 4, 2026 · Event occurred Jan 18, 2026

Report 3030539818-2026-00004 · MDR key 24505001

Device

Generic name

Pad,heating ,powered

Model number

25607 V1

Product problems

  • Overheating of Device

Patient

60 YR · Unknown

  • Insufficient Information

Narrative

Description of Event or Problem

MEMBER CALLED IN (B)(6)2026 AND STATED THAT ON (B)(6) SHE TRIED TO USE PRODUCT AT NIGHT ON HER BACK AND IT CAUGHT FIRE ON HER MATTRESS.

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.