BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLU-U

    MDR report key: 19998686 · Received August 15, 2024

    Report

    Report Number
    MW5158513
    Event Type
    Injury
    Date Received
    August 15, 2024
    Date of Event
    June 5, 2024
    Report Date
    August 13, 2024
    Manufacturer
    SUN PHARMACEUTICAL INDUSTRIES, INC.
    Product Code
    MVF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD LEVULAN KERASTICK+BLU-U DONE FOR PRECANCEROUS CONDITION ON MY FACE. 2 DAYS AFTER I NOTICED SWELLING AND INFECTIONS ON MY FACE. I BECAME SICK THE NEXT WEEK I WENT BACK TO MY DERMATOLOGIST AND THEY SAID IT'S ROSEOLA" AND INFECTED MY FACE IT'S NOT GONE IT'S BEEN 3 WEEKS. ALMOST 4. I HAD THIS DONE EITHER 2-3 YEARS AGO. BECAUSE AFTER HAVING COVID 8 TIME THESE SPOTS KEPT COMING BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2361864 BLU-U SYSTEM, LASER, PHOTODYNAMIC THERAPY MVF SUN PHARMACEUTICAL INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention| O ACTOS| ALLERGY MEDS | ASTHMA INHALERS 2| B12 ALLERGY CHILDREN MEDS| BABY ASPIRIN | BRIVIACT| LEVELER| NOVOLOG