BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUIK-FIX

    MDR report key: 291173 · Received August 17, 2000

    Report

    Report Number
    MW1019683
    Event Type
    Injury
    Date Received
    August 17, 2000
    Date of Event
    January 1, 2000
    Report Date
    August 17, 2000
    Manufacturer
    BRIMMS LABORATORY DIV OF BRIMMS, INC.
    Product Code
    EBO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CONTAINER HAS NO LABELING AS TO ITS INGREDIENTS AND IT HAS A VERY POTENT ODOR WHICH INCAPACITATED THE USER. THE USER APPLIED IT WITH A FAN IN USE. EVEN AFTER THE GLUE HAD DRIED AND THEY PLACED THEIR DENTURES IN THEIR MOUTH THE SMELL OF CHEMICALS FROM THE DENTURES WAS VERY POTENT. THE USER BELIEVES THAT WARNING AND CONTENT LABELS ARE INADEQUATE ESPECIALLY CONSIDERING THE RISK OF ALLERGIES TO THE PT. RPTR IS STILL QUITE SENSITIVE TO CHEMICAL ODORS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUIK-FIX DENTURE REPAIR KIT EBO BRIMMS LABORATORY DIV OF BRIMMS, INC. NA 129105

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR