BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACLEAR

    MDR report key: 22286706 · Received June 18, 2025

    Report

    Report Number
    3021550489-2025-00003
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    March 6, 2025
    Report Date
    June 16, 2025
    Manufacturer
    ACCLARO CORPORATION
    Product Code
    GEX
    UDI-DI
    00850039149047
    PMA / PMN Number
    K210847
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AN 80-YEAR-OLD PATIENT WAS TREATED USING THE ULTRACLEAR SYSTEM ON THE LEGS. THE TREATMENT WAS SUPERFICIAL AND PRODUCED SIGNIFICANTLY MORE TISSUE DAMAGE THAN EXPECTED BY THE DOCTOR. BOTH LEGS HAD POOR HEALING ON THE LOWER LEG. INVESTIGATION REVEALED THE PATIENT HAD INFLAMMATION IN BOTH LEGS PRIOR TO TREATMENT. ULTRACLEAR TREATMENT ON THE LEGS TAKES MORE TIME TO HEAL THAN OTHER AREAS OF THE BODY IN THE BEST CONDITIONS. THE PATIENTS PRE-EXISTING INFLAMMATION SHOULD NEVER HAVE BEEN TREATED WITH THE ULTRACLEAR ESPECIALLY AT THE PATIENT'S ADVANCED AGE. THIS WAS AN INAPPROPRIATE CANDIDATE FOR THIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864454 ULTRACLEAR FRACTION MID-IR LASER GEX ACCLARO CORPORATION AS-BM-00055 00850039149047

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Other