inforMED
InjuryIRT

SUNBEAM

Received Dec 17, 2024

Report 3014290933-2024-00046 · MDR key 20950422

Device

Generic name

Heating Pad

Model number

2304-504

Product problems

  • Labelling, Instructions for Use or Training Problem
  • Labelling, Instructions for Use or Training Problem

Patient

NA · Female

  • Burn(s)
  • Burn(s)

Narrative

Description of Event or Problem

CONSUMER ALLEGES USING THE HEATING PAD IN A LOVESEAT RECLINER FOR LEG PAIN AND RECEIVED A BURN ON HER RIGHT UPPER THIGH AREA AND ARM. 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.