BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORA-FIX

    MDR report key: 384305 · Received March 19, 2002

    Report

    Report Number
    MW4003229
    Event Type
    Injury
    Date Received
    March 19, 2002
    Manufacturer
    HOGIL PHARMACEUTICAL CORP
    Product Code
    KOQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER OPENED NEW CONTAINER OF ORA-FIX TO USE IT. CONSUMER HAD USED THIS PRODUCT FOR YEARS AND KNEW THAT IT SHOULD LOOK PINKISH AND CREAMY, THIS PARTICULAR TUBE WAS RED AND SANDY. CONSUMER PUT IT ON THE DENTURES AND WITHIN A FEW MINS CONSUMER BEGAN TO FEEL BURNING OF EYES AND THROAT, AND FEELING PECULIAR, THE PRODUCT GAVE CONSUMER A SEVERE SORE THROAT. CONSUMER TRIED TO WASH IT OFF IT TOOK CONSUMER 15 MINS TO DO SO, AND CONSUMER NOTED THAT THE ORA-FIX HAD EATEN AWAY AT THE DENTURES AND IT WAS STUCK TO THE ROOF OF MOUTH. NOW CONSUMER NOTED THAT THE STUFF IS EATING AWAY AT THE ACTUAL CONTAINER. CONSUMER RETURNED THE PRODUCT TO STORE WHERE CONSUMER HAD PURCHASED IT. THEN CALLED THE MFR CONSUMER LINE. SPOKE TO REP AND WAS TOLD TO RETURN THE TUBE AND THEIR INSURANCE DEPT WOULD GET IN TOUCH WITH CONSUMER. CONSUMER WENT TO STORE AND RETRIEVED THE TUBE OF ORA-FIX AND HAS IT AT HOME. CONSUMER ALSO HAS PURCHASED A NEW TUBE WITH DIFFERENT LOT NUMBER (# 80615" WICH IS USING NOW WITH OLD DENTURE, BECAUSE THE NEW ONES CONSUMER HAVE BEEN DAMAGED BY THE TUBE OF ORA-FIX IN QUESTION. CONSUMER RECEIVED SEVERE BURNING OF MOUTH WATERY EYES, AND SORE THROAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORA-FIX DENTURE ADHESIVE KOQ HOGIL PHARMACEUTICAL CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *