SUNBEAM
Received Aug 23, 2024
Report 3007790958-2024-00030 · MDR key 20048595
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 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 WHILE SLEEPING OR ON SOMEONE WHO IS SLEEPING" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION.
Description of Event or Problem
CONSUMER ALLEGES LAYING AGAINST HEATING PAD WHILE USING FOR SEVERE SPINAL ISSUES THEN FELL ASLEEP AND AWOKE TO BURNS ON HER RIGHT THIGH. THERE WAS NOT A REPORT OF PROPERTY DAMAGE(S) WITH THIS INCIDENT.