inforMED
InjuryIRT

LUMBAR & NECK REVOLVING PULSE HEAT THERAPY CUSHION

Received Oct 27, 2025 · Event occurred Jul 25, 2025

Report MW5178005 · MDR key 23391171

Device

Generic name

Pad, Heating, Powered

Manufacturer

Unknown

Model number

CM4000M

Product problems

  • Overheating of Device

Patient

42 YR · Female

  • Burn(s)
  • Burn(s)

Narrative

Description of Event or Problem

THE "LUMBAR & NECK REVOLVING PULSE HEAT THERAPY CUSHION" I PURCHASED IT ON (B)(6) 2025. I USED IT LAST ON (B)(6) 2025, BETWEEN 9-10PM AND THE PRODUCT BRUISED/BURNED ME AND LEFT A SCAR. I WENT TO THE ER ON (B)(6) 2025 WHERE I WAS EVALUATED, I ALSO BROUGHT THE MEDICAL DEVICE WITH ME, AND THE PROVIDER STATED THAT THE HEATING ELEMENT MIGHT HAVE WENT OUT ON IT THAT IS USED TO KEEP IT FROM OVERHEATING. I REPORTED THIS ISSUE TO SAFER PRODUCTS.GOV ON (B)(6) 2025 AND THEY ADVISED IN A LETTER/EMAIL THAT THIS IS MORE AN FDA ISSUE. REPORT NO. (B)(4). I BOUGHT THE PRODUCT ON FSA.COM BY CARING MILL.