BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUELIGHT PHOTODYNAMIC THERAPY

    MDR report key: 21961888 · Received May 5, 2025

    Report

    Report Number
    MW5169951
    Event Type
    Injury
    Date Received
    May 5, 2025
    Date of Event
    April 8, 2025
    Report Date
    April 28, 2025
    Manufacturer
    SUN PHARMACEUTICAL INDUSTRIES, INC. / LEVULAN KERASTICK
    Product Code
    MVF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BLUE LIGHT PROCEDURE DONE (B)(6) 2025. DAY AFTER BLUELIGHT PROCEDURE HAD A BLOODY NOSE WHICH LASTED 1.5 WEEKS. IT WAS MILD ONLY NOTICED WHEN BLOWING NOSE. I REMAINED STUFFY FOR 3 WEEKS. I REPORTED THIS TO DR. (B)(6) BLUELIGHT PHOTODYNAMIC THERAPY. BLUE LIGHT PROCEDURE DONE IN DOCTOR OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468881 BLUELIGHT PHOTODYNAMIC THERAPY SYSTEM, LASER, PHOTODYNAMIC THERAPY MVF SUN PHARMACEUTICAL INDUSTRIES, INC. / LEVULAN KERASTICK 4170

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female