BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APC II MINIATURE TWIN METAL BRACKET

    MDR report key: 628642 · Received August 19, 2005

    Report

    Report Number
    2020467-2005-00006
    Event Type
    Injury
    Date Received
    August 19, 2005
    Date of Event
    July 16, 2005
    Report Date
    August 4, 2005
    Manufacturer
    3M UNITEK
    Product Code
    DYW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPERIENCED AN ALLERGIC REACTION SHORTLY AFTER BEGINNING ORTHODONTIC TREATMENT. A DERMATOLOGIST DETERMINED THAT PATIENT IS ALLERGIC TO NICKEL AND BLEACHING AGENTS. TREATMENT FOR PATIENT'S ALLERGIC REACTION INCLUDED REMOVAL OF THE ORTHDONTIC APPLIANCES AND A PRESCRIPTION STEROID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APC II MINIATURE TWIN METAL BRACKET ORTHODONTIC METAL BRACKET DYW 3M UNITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention