inforMED
InjuryIRT

SUNBEAM

Received May 29, 2025 · Event occurred Apr 28, 2025

Report 3010805625-2025-00026 · MDR key 22105512

Device

Generic name

Heating Pad

Model number

UNK

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 USE WHILE SLEEPING" 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 WHILE USING THE HEATING PAD SHE FELL ASLEEP AND AWOKE TO BURN(S) ON HER LEFT BUTTOCK AND BUTT CRACK. THERE WAS NOT A REPORT OF PROPERTY DAMAGE(S) WITH THIS INCIDENT.