SUNBEAM
Received May 29, 2025 · Event occurred Apr 28, 2025
Report 3010805625-2025-00026 · MDR key 22105512
Device
Product problems
- Labelling, Instructions for Use or Training Problem
- Labelling, Instructions for Use or Training Problem
Patient
NA · Female
- Burn(s)
- 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 USE WHILE SLEEPING" 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. THERE IS AN INSTRUCTION THAT STATES, "DO NOT USE ON AREAS OF INSENSITIVE SKIN" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION.
Description of Event or Problem
CONSUMER ALLEGES WHILE USING THE HEATING PAD SHE FELL ASLEEP AND AWOKE TO BURN(S) ON HER LEFT BUTTOCK AND BUTT CRACK. THERE WAS NOT A REPORT OF PROPERTY DAMAGE(S) WITH THIS INCIDENT.