SUNBEAM
Received May 29, 2026 · Event occurred Feb 7, 2025
Report 3010805625-2026-00013 · MDR key 25331362
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, "THIS PAD IS NOT TO BE USED ON OR BY AN INVALID, A SLEEPING OR UNCONSCIOUS PERSON, A PERSON WITH DIABETES, OR A PERSON WITH POOR BLOOD CIRCULATION OR INSENSITIVITY TO HEAT" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION. 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. HEATING PAD IS BUNCHED/CRUSHED WHICH SHOWS ABUSE OF THE PRODUCT AND A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. THIS INCIDENT IS THE DIRECT RESULT OF CONSUMER MISUSE/ABUSE OF THE PRODUCT.
Description of Event or Problem
AN ATTORNEY'S OFFICE IS FILING A LETTER NOTICE ALLEGING THAT A HEATING PAD WAS THE CAUSE OF A BURN TO ITS CLIENT'S RIGHT ABDOMEN. THERE WAS NOT A REPORT OF PROPERTY DAMAGE(S) WITH THIS INCIDENT.