BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE LIGHT-PHOTODYNAMIC THERAPY ILLUMINATOR MODEL 4170

    MDR report key: 8599968 · Received May 9, 2019

    Report

    Report Number
    MW5086528
    Event Type
    Injury
    Date Received
    May 9, 2019
    Date of Event
    April 29, 2019
    Report Date
    May 7, 2019
    Manufacturer
    DUSA PHARMACEUTICALS, INC.
    Product Code
    MVF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD LEVULAN KERASTICK +BLU-U. BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR MODEL 4170 TREATMENT. AT ADVANCED DERMATOLOGY AND COSMETIC SURGERY, IN THE (B)(6). I WAS UNDER THE BLUE LIGHT FOR 4 MINS. MY FACE STARTED BURNING IMMEDIATELY AND THE LITTLE FAN THEY GAVE TO USE WAS ONLY ABLE TO HELP SLIGHTLY. THEY THEN SPRAYED WATER ON MY FACE TO HELP COOL IT. WITHIN A COUPLE MINS MY FACE FELT LIKE THE BLOOD WAS BOILING UNDER MY SKIN. I HAD THEM STOP THE TREATMENT AND WENT HOME. I WAS UNABLE TO SLEEP FOR TWO DAYS BECAUSE OF THE PAIN. MY FACE WAS BLEEDING IN SEVERAL PLACES, AND IT TOOK 6 DAYS FOR THE PAIN TO SUBSIDE. I HAVE A PICTURE OF THE PRODUCT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387295 BLUE LIGHT-PHOTODYNAMIC THERAPY ILLUMINATOR MODEL 4170 SYSTEM, LASER, PHOTOGYNAMIC THERAPY MVF DUSA PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR