BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLU-U TREATMENT

    MDR report key: 23541864 · Received November 12, 2025

    Report

    Report Number
    MW5178786
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    November 6, 2025
    Report Date
    November 8, 2025
    Manufacturer
    SUN PHARMACEUTICAL INDUSTRIES, INC.
    Product Code
    MVF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SEVERE REACTION TO LEILANI KERASTICK AND BLU-U TREATMENT. SEVERE REDNESS, BURNING AND SWELLING TO ENTIRE FACE NOT JUST AREAS OF ACTINIC KERATOSES BEING TREATED. EVEN LIPS SWOLLEN. AFTER 48 HOURS LITTLE DISS MINING OF REACTIONS. PATIENT CODES: 1840, 4540, 4577. DEVICE CODE: 1524. REFERENCE REPORT: MW5178785.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2165335 BLU-U TREATMENT SYSTEM, LASER, PHOTODYNAMIC THERAPY MVF SUN PHARMACEUTICAL INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other ATROVASTAIN.| LEILANI KERASTICK.