BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXODENT

    MDR report key: 1812355 · Received August 18, 2010

    Report

    Report Number
    MW5017167
    Event Type
    Injury
    Date Received
    August 18, 2010
    Manufacturer
    PROCTOR 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 FOR APPROXIMATELY (B)(6) 1998 UNTIL MY MOUTH STARTED TINGLING AND PAIN IN MY NECK, BACK, AND HANDS, MOUTH, FEET, ARMS. NUMB AND TINGLING ON JAW, LIP. NUMB FEET. I WANT TO BE CHECKED FOR NEUROPATHY. MY FACE TINGLES AND FEELS NUMB. I REALLY WANT TO GET BETTER. GUMS GET RED AND SORE AND WOULD BLEED. TINGLING IN FACE, HANDS, TONGUE, LIP SWOLLEN. CRAMPS IN JAWS. DOSE OR AMOUNT: DENTURE CREAM. FREQUENCY: 2 DAILY. ROUTE: ORAL. DATES OF USE: (B)(6) 1998 UNTIL (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: DENTURE ADHESIVE CREAM. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT POLYGRIP KOO PROCTOR GAMBLE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S