HANDY SOLUTIONS
Received May 21, 2026 · Event occurred Mar 25, 2026
Report 3030539818-2026-00015 · MDR key 25250793
Device
Product problems
- Temperature Problem
Patient
64 YR · Female
- 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
HEATING PAD MADE BY VAVAJO MANUFACTURING COMPANY INC. OVERHEATED AND BURNED THROUGH THE FABRIC OF THE HEATING PAD. NO PATIENT INJURY.