BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAINLESS STEEL RETAINER/BRACE

    MDR report key: 11659 · Received February 22, 1994

    Report

    Report Number
    MW1000845
    Event Type
    Injury
    Date Received
    February 22, 1994
    Date of Event
    January 1, 1988
    Report Date
    February 1, 1994
    Manufacturer
    UNITEK CORP.
    Product Code
    DYJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ORTHODONTIC BRACES AND RETAINERS CAUSED TONGUE CANCER. THERE IS A DOCUMENTED LEACHING OF CARCINOGEN NICKEL AND CHROMIUM INTO PT'S SALIVA. (ALSO SEE MW1000844 AND 1000846.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAINLESS STEEL RETAINER/BRACE Implant DYJ UNITEK CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Not Applicable| H| L| R