inforMED
InjuryIRT

SUNBEAM

Received Mar 20, 2025 · Event occurred Mar 1, 2025

Report 3010805625-2025-00012 · MDR key 21652618

Device

Generic name

Heating Pad

Model number

938-511

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.

Description of Event or Problem

CONSUMER ALLEGES WHILE USING THE HEATING PAD SHE RECEIVED A BURN ON HER LEFT ARM NEAR HER ELBOW. THERE WAS NOT A REPORT OF PROPERTY DAMAGE(S) WITH THIS INCIDENT.