InjuryIRT
HANDY SOLUTIONS
Received Mar 23, 2026
Report 1000065475-2026-00004 · MDR key 24668608
Device
Product problems
- Device Emits Odor
- Overheating of Device
Patient
NA · Unknown
- Full thickness (Third Degree) Burn
- Blister
Narrative
Description of Event or Problem
FROM RECEIVED MEDWATCH LETTER. USERS 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 EMERGENCY ROOM, GOING TO BURN AND WOUND PLASTIC SURGERY CENTER ON (B)(6) 2026.