BEUDAMED
    FDA Adverse Event Summary report: N

    MULTIPLE BRANDS

    MDR report key: 772160 · Received October 3, 2006

    Report

    Report Number
    MW4004241
    Date Received
    October 3, 2006
    Report Date
    October 3, 2006
    Manufacturer
    *
    Product Code
    KOM
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    CONSUMER BELIEVES THAT DENTAL ADHESIVES SHOULD NOT BE CONSIDERED MEDICAL DEVICES AND SHOULD REQUIRE LISTS ON INGREDIENTS ON THE LABELING. HE BELIEVES THEY SHOULD BE CLASSIFIED AS DRUGS SINCE THEY ARE PUT IN THE MOUTH AND THE INGREDIENTS ARE PARTIALLY SWALLOWED AND ABSORBED BY THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIPLE BRANDS DENTAL/DENTURE ADHESIVES KOM * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *