inforMED
InjuryIRT

CVS

Received Jan 10, 2025 · Event occurred Jul 10, 2023

Report 3007790958-2025-00002 · MDR key 21126005

Device

Generic name

Heating Pad

Model number

2024-511

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

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