BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACLEAR

    MDR report key: 22286590 · Received June 18, 2025

    Report

    Report Number
    3021550489-2025-00001
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    February 3, 2025
    Report Date
    June 16, 2025
    Manufacturer
    ACCLARO CORPORATION
    Product Code
    GEX
    UDI-DI
    00850039149009
    PMA / PMN Number
    K210847
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    POOR HEALING ON THE PATIENTS NECK AFTER ULTRACLEAR ABLATIVE LASER TREATMENT. LED TO AN INFECTION THAT REQUIRED PRESCRIPTION TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496526 ULTRACLEAR FRACTIONAL MID-IR LASER GEX ACCLARO CORPORATION AS-BB-00055 00850039149009

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention