BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXODENT

    MDR report key: 1441352 · Received August 13, 2009

    Report

    Report Number
    MW5012443
    Event Type
    Injury
    Date Received
    August 13, 2009
    Date of Event
    April 1, 2009
    Report Date
    July 22, 2009
    Manufacturer
    PROCTER & GAMBLE
    Product Code
    KOL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED FIXODENT FROM APPROXIMATELY 1998-2008. THEN I CHANGED TO SEA BOND FROM 2008-2009. FOUND OUT SEA BOND IS ALSO FULL OF ZINC. NOTHING ON LABEL STATING ZINC CONTENTS. WHILE USING BOTH PRODUCTS, I BEGAN EXPERIENCING NUMBNESS AND TINGLING IN MY EXTREMITIES. IN 2009, I WAS DIAGNOSED WITH NEUROPATHY. BLOOD TEST SHOWED HIGH LEVELS OF ZINC. MY NEUROPATHY IS PERMANENT AND REQUIRES CONTINUED MEDICAL CARE AND TREATMENT. DOSE: #1 DENTURE CREAM. #2 DENTURE STRIPS. FREQUENCY: #1 TWICE DAILY. #2 ONCE DAILY. ROUTE: ORAL. DATES OF USE: #1 1998-2008. #2 2008-2009. EVENT ABATED AFTER USE: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT NONE KOL PROCTER & GAMBLE
    2 SEA-BOND NONE KOL COMBE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| R