inforMED
InjuryIRT

SUNBEAM

Received Nov 20, 2023 · Event occurred Aug 10, 2023

Report 3010805625-2023-00071 · MDR key 18168846

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

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.

Description of Event or Problem

CONSUMER ALLEGES WHILE USING HER HEATING PAD SHE FELL ASLEEP AND AWOKE TO A BURN ON HER LEFT BUTTOCK. THERE WAS NOT A REPORT OF PROPERTY DAMAGE(S) WITH THIS INCIDENT.