SUNBEAM
Received Sep 19, 2024
Report 3007790958-2024-00034 · MDR key 20257044
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" 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
CONSUMER ALLEGES USING THE HEATING PAD IN BED FOR ARTHRITIS PAIN AND FELL ASLEEP WHILE USING IT. CONSUMER ALLEGES SHE RECEIVED A BURN ON THE BACK SIDE OF HER RIGHT HIP/BUTTOCK. THERE WAS NOT A REPORT OF PROPERTY DAMAGE(S) WITH THIS INCIDENT.
Description of Event or Problem
CONSUMER ALLEGES USING THE HEATING PAD IN BED FOR ARTHRITIS PAIN AND FELL ASLEEP WHILE USING IT. CONSUMER ALLEGES SHE RECEIVED A BURN ON THE BACK SIDE OF HER RIGHT HIP/BUTTOCK. 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 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" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION.