inforMED
InjuryIRT

SUNBEAM

Received Feb 3, 2023 · Event occurred Oct 16, 2022

Report 3010805625-2023-00013 · MDR key 16290811

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

Female

  • Burn(s)
  • Burn(s)

Narrative

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 BODY. THERE WAS NOT A REPORT OF PROPERTY DAMAGE 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.