HANDY SOLUTIONS
Received May 21, 2026 · Event occurred Mar 26, 2026
Report 3030539818-2026-00013 · MDR key 25250525
Device
Product problems
- Temperature Problem
Patient
65 YR · Male
- 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 (B)(4) AND NO DEFECTS IDENTIFIED. THIRD PART TESTING REPORT (B)(4).
Description of Event or Problem
PATIENT USING AN OTC HEATING PAD WRAP FOR SHOULDER AND NECK FROM MANUFACTURER-NAVAJO MANUFACTURING COMPANY INC. ON LOW SETTING AND EXPERIENCED PRODUCT OVERHEATING . PATIENT EXPERIENCED BURNING AND BLISTERING TO NECK AND SHOULDER.