BEUDAMED
    FDA Adverse Event Summary report: N

    SUPER POLYGRIP

    MDR report key: 328554 · Received April 19, 2001

    Report

    Report Number
    MW4002987
    Date Received
    April 19, 2001
    Report Date
    April 2, 2001
    Manufacturer
    BLOCK DRUG CO INC
    Product Code
    KOM
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT WANTED TO KNOW THE INGREDIENTS IN SUPER POLYGRIP BECAUSE THEY SOMETIMES SWALLOW THIS DENTURE ADHESIVE. SINCE THE PRODUCT IS CONSIDERED TO BE A DEVICE, THEY FOUND NO INGREDIENT STATEMENT ON THE LABEL. CALLED THE CO AND THEY REFUSED TO TELL COMPLAINANT THE INGREDIENTS. COMPLAINANT THINKS THAT THE FDA SHOULD SPONSOR LEGAL CHANGES TO REQUIRE THE LISTING OF INGREDIENTS ON ORAL DEVICES WHICH ARE NOT INTACT PIECES LIKE OTHER DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17793 SUPER POLYGRIP DENTURE ADHESIVE KOM BLOCK DRUG CO INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO