BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXODENT

    MDR report key: 2033273 · Received March 25, 2011

    Report

    Report Number
    MW5019966
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    July 1, 2010
    Report Date
    February 1, 2011
    Manufacturer
    PROCTER & GAMBLE
    Product Code
    KOO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED FIXODENT FROM (B)(6) 2007 - UNTIL 2011. IN 2010, I BEGAN EXPERIENCING NUMBNESS, SEVERE TINGLING IN MY FINGERS IN (B)(6). IT LATER SPREAD IN MY LOWER RIGHT ARM, "BOTH" HANDS, LOWER RIGHT LEG AND BOTTOM OF FEET. HAD SURGERY ON (B)(6) FOR WHAT THEY THOUGHT WOULD CURE THIS, BUT IT DIDN'T. I HAVE TINGLING YET STILL IN BOTH HANDS W/ VERY VERY LITTLE FEELING, NUMBNESS, AND IN BOTH FEET (BOTTOM). DOSE OR AMOUNT: DENTURE CREAM, FREQUENCY: 2-3 DAILY, ROUTE: ORAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| S