inforMED
InjuryIRT

SUNBEAM

Received Oct 29, 2024 · Event occurred Dec 16, 2023

Report 3007790958-2024-00041 · MDR key 20557313

Device

Generic name

Heating Pad

Model number

2013-505

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

AN ATTORNEY'S OFFICE IS FILING A LETTER NOTICE UNDER CASE REFERENCE NUMBER: (B)(4) ALLEGING THAT A HEATING PAD WAS THE CAUSE OF A BURN TO ITS CLIENT'S THIGH. THERE WAS NOT A REPORT OF PROPERTY DAMAGE(S) WITH THIS INCIDENT.