BEUDAMED
    FDA Adverse Event Summary report: N

    ORA-FIX

    MDR report key: 20744 · Received March 27, 1995

    Report

    Report Number
    MW1005573
    Date Received
    March 27, 1995
    Report Date
    March 22, 1995
    Manufacturer
    REED AND CARNICK
    Product Code
    KOP
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT EXPRESSED CONCERN BECAUSE THE PRODUCT(S) DO NOT HAVE THE INGREDIENTS LISTED. VARIOUS DENTURE PRODUCTS HAVE NO LISTING OF INGREDIENTS ON THE LABELING. (ALSO SEE 1005568.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORA-FIX KOP REED AND CARNICK

    Patients

    Seq Age Sex Outcome Treatment
    1 *