BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT

    MDR report key: 1386579 · Received May 15, 2009

    Report

    Report Number
    MW5011128
    Event Type
    Other
    Date Received
    May 15, 2009
    Date of Event
    April 13, 2009
    Report Date
    April 2, 2009
    Manufacturer
    PROCTER & GAMBLE
    Product Code
    KOL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED FIXODENT & POLIGRIP FROM 1974 TO 2009 AND WILL ALSO USE IT UNTIL I DIE BECAUSE THIS IS THE ONLY WAY MY TEETH WILL STAY IN. I FEEL NUMBNESS AND TINGLING IN MY HAND AND FEET. I DO HAVE COPPER AND A LITTLE HIGH LEVELS OF ZINC IN MY BLOOD. DOSE: DENTURE CREAM. FREQUENCY: 3 TIMES A DAY. ROUTE: ORAL AND POWDERED. DATES OF USE: 1974 - 2009. DIAGNOSIS: DENTURE ADHESIVE CREAM. EVENT ABATED AFTER USE STOPPED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT NONE KOL PROCTER & GAMBLE
    2 POLIGRIP NONE KOL *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other