InjuryFTC
PHOTHERA
Received Jun 25, 2025 · Event occurred May 23, 2025
Report MW5171945 · MDR key 22338297
Device
Generic name
Light, Ultraviolet, Dermatological
Manufacturer
The Daavlin Distributing Co.Product problems
- Inadequate Instructions for Non-Healthcare Professional
- Output Problem
Patient
72 YR · Male
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
PATIENT HAD CLEARLINK CONTROLLER DURING INITIAL TREATMENT, THEN AFTER 1 TREATMENT ASKED HIM TO PUT IN DOSE . CLEARLINK IS TO PREVENT PATIENTS PUTTING IN THEIR OWN DOSE TO PREVENT BURNS. PATIENT DID NOT ENTER ANYTHING THANKFULLY AND WAS NEAR MISS.