BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACLEAR

    MDR report key: 22286658 · Received June 18, 2025

    Report

    Report Number
    3021550489-2025-00002
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    October 15, 2024
    Report Date
    June 16, 2025
    Manufacturer
    ACCLARO CORPORATION
    Product Code
    GEX
    UDI-DI
    00850039149429
    PMA / PMN Number
    K233803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON THE SEVENTH DAY AFTER TREATMENT, THE PATIENT REPORTED SKIN LESIONS. FOLLOWING A MEDICAL EXAMINATION, A VIRAL INFECTION IS SUSPECTED. PATIENT WAS PRESCRIBED CEFIXORAL AND DIFLUCAN TO PREVENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911507 ULTRACLEAR MIDIR FRACTIONAL FIBER LASER GEX ACCLARO CORPORATION AS-WB-00055 00850039149429

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other