inforMED
MalfunctionILY

LIGHT RELIEF

Received Aug 12, 2023

Report MW5138542 · MDR key 17531629

Device

Generic name

Lamp, Infrared, Therapeutic Heating

Manufacturer

Unknown

Product problems

  • Device-Device Incompatibility
  • Device-Device Incompatibility

Patient

Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT HAD CONCERNS OF DEVICE INTERACTION BETWEEN THE LIGHT RELIEF DEVICE AND THEIR ST. JUDE DEVICE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).