inforMED
InjuryIRT

SUNBEAM

Received Feb 21, 2025

Report 3010805625-2025-00007 · MDR key 21434475

Device

Generic name

Heating Pad

Model number

732-500

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. 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 WHILE USING THE HEATING PAD SHE FELL ASLEEP THEN AWOKE TO BURNS ON HER LEFT THIGH/HIP AREAS. THERE WAS NOT A REPORT OF PROPERTY DAMAGE(S) WITH THIS INCIDENT.

Description of Event or Problem

CONSUMER ALLEGES WHILE USING THE HEATING PAD SHE FELL ASLEEP THEN AWOKE TO BURNS ON HER LEFT THIGH/HIP AREAS. 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 OR ON SOMEONE WHO IS SLEEPING" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION.