BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLU-U LIGHT THERAPY

    MDR report key: 11201384 · Received January 19, 2021

    Report

    Report Number
    MW5098885
    Event Type
    Injury
    Date Received
    January 19, 2021
    Date of Event
    January 14, 2021
    Report Date
    January 15, 2021
    Manufacturer
    DUSA PHARMACEUTICALS, INC.
    Product Code
    MVF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY DERMATOLOGIST APPLIED LEVULAN TO MY FACE AND NECK AREA FOR 2 HOURS, THEN I RECEIVED THE BLU-U LIGHT THERAPY FOR ABOUT 16 MINUTES. MY FACE AND NECK WERE SEVERELY SUNBURNT IMMEDIATELY AFTER (AND PROBABLY DURING) THE TREATMENT. MY HEALTHCARE PROVIDER WAS AWARE THAT I WAS ALSO TAKING DOXYCYCLINE 20MG BID AT THE TIME. I BELIEVE (AS A PHARMACIST) THAT THERE NEEDS TO BE AN ACTUAL CONTRAINDICATION FOR THIS THERAPY FOR PEOPLE ON KNOWN PHOTOSENSITIZING MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95464 BLU-U LIGHT THERAPY SYSTEM, LASER, PHOTODYNAMIC THERAPY MVF DUSA PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR