BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APC PLUS, CLARITY, MINI UNI-TWIN, VICTORY SERIES

    MDR report key: 2622884 · Received May 9, 2012

    Report

    Report Number
    2020467-2012-00001
    Event Type
    Injury
    Date Received
    May 9, 2012
    Date of Event
    March 1, 2012
    Report Date
    May 8, 2012
    Manufacturer
    3M UNITEK
    Product Code
    DYH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    APPLICABLE 510(K)S: K020394, K944286. LABELS FOR ADHESIVE-COATED BRACKETS DISPLAY THE FOLLOWING WARNING: POSSIBLE ACRYLIC SENSITIVITY. LABELS OF STAINLESS STEEL BRACKETS AND BUCCAL TUBES DISPLAY THE FOLLOWING WARNING: THIS PRODUCT CONTAINS NICKEL AND/OR CHROMIUM. A SMALL PERCENTAGE OF THE POPULATION IS KNOWN TO BE ALLERGIC TO NICKEL AND/OR CHROMIUM. IF AN ALLERGIC REACTION OCCURS, DIRECT PT TO CONSULT A PHYSICIAN.

    Description of Event or Problem · 1

    PT HAD AN ALLERGIC REACTION TO HER ORTHODONTIC BRACKETS AND ADHESIVE. FIRST THE UPPER ARCH WAS BONDED WITH CERAMIC BRACKETS, WHICH CAUSED A SLIGHT ALLERGIC REACTION. AT THE NEXT APPOINTMENT THE LOWER ARCH WAS BONDED WITH STAINLESS STEEL BRACKETS, WHICH CAUSED A GREATER ALLERGIC REACTION. THE ORTHODONTIST HAD TO REMOVE ALL OF THE BRACKETS. PT WAS REFERRED TO A PHYSICIAN, ACCORDING TO PRODUCT WARNING RECOMMENDATION. PT WAS FOUND TO BE ALLERGIC TO THE METAL AND ADHESIVE. NO MEDICATION WAS PRESCRIBED FOR THE ALLERGIC REACTION. PARENT PREFERRED HOMEOPATHIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APC PLUS, CLARITY, MINI UNI-TWIN, VICTORY SERIES ORTHODONTIC ADHESIVE, BRACKETS, TUBES DYH 3M UNITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention LIGATURES| ORTHODONTIC ARCHWIRES AND