BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXODENT

    MDR report key: 2004005 · Received February 25, 2011

    Report

    Report Number
    MW5019575
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    August 15, 2009
    Report Date
    February 14, 2011
    Manufacturer
    PROCTER & GAMBLE
    Product Code
    KOO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED FIXODENT FROM APPROX (B)(6) 1995 UNTIL (B)(6) 2011. WHILE USING FIXODENT, I BEGAN TO EXPERIENCE NUMBNESS AND TINGLING IN MY EXTREMITIES ON (B)(6) 2009 AND WAS DIAGNOSED WITH NEUROPATHY. BLOOD TEST AT THAT TIME SHOWED THAT I HAD HIGH LEVELS OF ZINC AND LOW LEVELS OF COPPER IN MY BLOOD. MY NEUROPATHY IS PERMANENT AND REQUIRES CONTINUED MEDICAL CARE AND TREATMENT. DOSE OR AMOUNT: DENTURE CREAM. FREQUENCY: TWICE DAILY. ROUTE: ORAL. EVENT NOT ABATED AFTER USE STOPPED OR DOSE REDUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT DENTURE ADHESIVE CREAM KOO PROCTER & GAMBLE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| S