BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACLEAR

    MDR report key: 22286661 · Received June 18, 2025

    Report

    Report Number
    3021550489-2025-00004
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    February 25, 2025
    Report Date
    June 17, 2025
    Manufacturer
    ACCLARO CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K233803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON THE FIFTH DAY AFTER TREATMENT, THE PATIENT REPORTED THE FACE WAS COVERED IN CLEAR SIGNS OF INFECTION. FOLLOWING A MEDICAL EXAMINATION, PATIENT WAS PUT ON ANTIVIRAL MEDICATION (VALACYCLOVIR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911510 ULTRACLEAR MIDIR FRACTIONAL FIBER LASER GEX ACCLARO CORPORATION AS-WB-00055

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Female Other