inforMED
InjuryIRT

SUNBEAM

Received Jan 28, 2021 · Event occurred Jan 11, 2021

Report 3010805625-2021-00013 · MDR key 11244320

Device

Generic name

Heating Pad

Model number

938-511

Product problems

  • Improper or Incorrect Procedure or Method

Patient

Not reported

  • Burn(s)
  • Burn(s)

Narrative

Additional Manufacturer Narrative

CONSUMER ADMITS TO SLEEPING WHILE USING THE HEATING PAD WHICH IS A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. 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, "BURNS CAN OCCUR REGARDLESS OF CONTROL SETTING, CHECK SKIN UNDER PAD FREQUENTLY" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION.

Description of Event or Problem

CONSUMER ALLEGES LAYING AGAINST HER HEATING PAD WHILE IN BED THEN FELL ASLEEP THEN AWOKE TO A BURN ON HER LEFT BUTTOCK.

Additional Manufacturer Narrative

CONSUMER ADMITS TO SLEEPING WHILE USING THE HEATING PAD WHICH IS A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. 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, "BURNS CAN OCCUR REGARDLESS OF CONTROL SETTING, CHECK SKIN UNDER PAD FREQUENTLY" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION. CONSUMER ADMITS TO LAYING ON THE HEATING PAD WHICH IS ABUSE OF THE PRODUCT AND A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. 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 LAYING AGAINST HER HEATING PAD WHILE IN BED THEN FELL ASLEEP THEN AWOKE TO A BURN ON HER LEFT BUTTOCK.