inforMED
MalfunctionFTC

PHOTHERA

Received Jun 24, 2025 · Event occurred May 22, 2025

Report MW5171907 · MDR key 22329528

Device

Generic name

Light, Ultraviolet, Dermatological

Model number

PHOTHERA 600-4L

Product problems

  • Protective Measures Problem

Patient

72 YR · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PATIENT HAD CLEARLINK CONTROLLER WHEN WE WERE SETTING IT UP, AFTER UNIT TIMED OUT IT ASKED HER FOR DOSE. CLEARLINK IS USED TO PREVENT PATIENT ENTERING OWN SETTING TO PREVENT BURNS.