FDA Adverse Event
Malfunction
Summary report: N
HANDY SOLUTIONS NECK AND SHOULDER HEATING PAD
MDR report key: 24521472
·
Received March 5, 2026
Report
- Report Number
- MW5184799
- Event Type
- Malfunction
- Date Received
- March 5, 2026
- Date of Event
- February 1, 2026
- Report Date
- March 2, 2026
- Manufacturer
- NAVAJO MANUFACTURING COMPANY INC.
- Product Code
- IRT
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584269 | HANDY SOLUTIONS NECK AND SHOULDER HEATING PAD | PAD, HEATING, POWERED | IRT | NAVAJO MANUFACTURING COMPANY INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female |