SUNBEAM
Received Jun 25, 2026 · Event occurred Apr 3, 2026
Report 3010805625-2026-00016 · MDR key 25621321
Device
Product problems
- Labelling, Instructions for Use or Training Problem
Patient
NA · Female
- Burn(s)
Narrative
Additional Manufacturer Narrative
THERE IS AN INSTRUCTION THAT STATES, "BURNS CAN OCCUR REGARDLESS OF CONTROL SETTING, CHECK SKIN UNDER PAD FREQUENTLY" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION. THERE IS AN INSTRUCTION THAT STATES, "DO NOT SIT ON, AGAINST, OR CRUSH PAD-AVOID SHARP FOLDS. PLACE PAD ON TOP OF AND NOT UNDER THE PART OF BODY NEEDING HEAT" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION.
Description of Event or Problem
AN ATTORNEY'S OFFICE IS FILING A LETTER NOTICE UNDER CASE REFERENCE NUMBER (B)(4) ALLEGING THAT A HEATING PAD WAS THE CAUSE OF A BURN TO ITS CLIENT'S RIGHT HIP. THERE WAS NOT A REPORT OF PROPERTY DAMAGE(S) WITH THIS INCIDENT.