BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M¿ APC¿ FLASH-FREE VICTORY SERIES¿ LOW PROFILE BRACKET

    MDR report key: 21979275 · Received May 7, 2025

    Report

    Report Number
    2020467-2025-00003
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    April 11, 2025
    Report Date
    May 7, 2025
    Manufacturer
    3M UNITEK CORPORATION
    Product Code
    EJF
    PMA / PMN Number
    K113197
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO LOT NUMBER WAS PROVIDED, AND NO SAMPLES WERE RETURNED FOR ANALYSIS; THEREFORE, CAUSE COULD NOT BE DETERMINED. THIS PRODUCT CONTAINS NICKEL AND/OR CHROMIUM. MEDICAL HISTORY INCLUDES IRRITATION FROM JEWELRY. A SMALL PERCENTAGE OF THE POPULATION IS KNOWN TO BE ALLERGIC TO NICKEL AND/OR CHROMIUM. SOLVENTUM WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 0

    3M¿ APC¿ FLASH-FREE VICTORY SERIES¿ LOW PROFILE BRACKET WERE BONDED USING A 3M¿ DIGITAL BONDING TRAY. THE PATIENT DEVELOPED HIVES/WELTS ON THE FACE, NECK, AND TORSO AFTER THE BRACKETS WERE PLACED. PATIENT WAS PRESCRIBED CLARITIN AND PREDNISONE. AFTER TEN DAYS, THE BRACES WERE REMOVED DUE TO PATIENT CONCERN OF POSSIBLE WORSENING OF THE SYMPTOMS WHEN NO LONGER TAKING MEDICATIONS PRESCRIBED. PATIENT INDICATED SHE GETS SORE/IRRITATED FROM CHEAP EARRINGS AND COSTUME JEWELRY. DUE TO THE BROAD NATURE OF THE HIVES, THE REPORTER DID NOT THINK THE HIVES WERE DUE TO GLOVES OR OTHER PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886325 3M¿ APC¿ FLASH-FREE VICTORY SERIES¿ LOW PROFILE BRACKET BRACKET, METAL, ORTHODONTIC EJF 3M UNITEK CORPORATION NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Required Intervention