BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTROL DENTURE ADHESIVE

    MDR report key: 48189 · Received November 8, 1996

    Report

    Report Number
    MW4001696
    Event Type
    Malfunction
    Date Received
    November 8, 1996
    Report Date
    June 20, 1996
    Manufacturer
    BLOCK DRUG CO.
    Product Code
    KOP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 9/28/01: THE RESULTS OF PHYSICAL AND CHEMICAL TESTS CONDUCTED ON THE BATCH BEFORE PACKAGING SHOWED FULL COMPLIANCE WITH SPECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENTROL DENTURE ADHESIVE DENTURE ADHESIVE KOP BLOCK DRUG CO. * BW94022

    Patients

    Seq Age Sex Outcome Treatment
    1 *