BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLU-U

    MDR report key: 14218651 · Received April 26, 2022

    Report

    Report Number
    MW5109369
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    March 21, 2022
    Report Date
    April 22, 2022
    Manufacturer
    SUN PHARMA / DUSA PHARMACEUTICALS, INC.
    Product Code
    MVF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SEVERE ALLERGIC REACTION TO LEVULAN KERASTICK IS A PRESCRIPTION MEDICINE USED ON THE SKIN WITH BLUE LIGHT TREATMENT (BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY OR PDT) FOR THE TREATMENT OF MINIMALLY TO MODERATELY THICK ACTINIC KERATOSES (AK'S) OF THE FACE, SCALP, OR UPPER ARMS. STILL SUFFERING SUBSTANTIAL PAIN AND DISCOMFORT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840996 BLU-U SYSTEM, LASER, PHOTODYNAMIC THERAPY MVF SUN PHARMA / DUSA PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| S| H| L