inforMED
InjuryIRT

SUNBEAM

Received Mar 20, 2025

Report 3010805625-2025-00014 · MDR key 21652629

Device

Generic name

Heating Pad

Model number

2005-525-CN

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 ON AREAS OF INSENSITIVE SKIN" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION.

Description of Event or Problem

CONSUMER ALLEGES USING THE HEATING PAD UNDERNEATH HER ARM AND WRAPPED OVER HER ABDOMEN. CONSUMER ALLEGES SHE RECEIVED A BURN ON THE BOTTOM OF HER RIGHT ARM AND IT MELTED HER BANDAGE FROM HER COLOSTOMY BAG ONTO HER SKIN.

Description of Event or Problem

CONSUMER ALLEGES USING THE HEATING PAD UNDERNEATH HER ARM AND WRAPPED OVER HER ABDOMEN. CONSUMER ALLEGES SHE RECEIVED A BURN ON THE BOTTOM OF HER RIGHT ARM AND IT MELTED HER BANDAGE FROM HER COLOSTOMY BAG ONTO HER SKIN.

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 ON AREAS OF INSENSITIVE SKIN" 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.