SUNBEAM
Received Jan 29, 2026 · Event occurred Nov 14, 2025
Report 3007790958-2026-00001 · MDR key 24210558
Device
Product problems
- Labelling, Instructions for Use or Training Problem
Patient
NA · Female
- Burn(s)
Narrative
Description of Event or Problem
AN ATTORNEY'S OFFICE IS FILING A LETTER NOTICE UNDER CASE REFERENCE NUMBER (B)(6) ALLEGING THAT A HEATING PAD WAS THE CAUSE OF A BURN TO ITS CLIENT'S BODY. THERE WAS NOT A REPORT OF PROPERTY DAMAGE(S) WITH THIS INCIDENT.
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 USE ON AREAS OF INSENSITIVE SKIN" 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.