BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXODENT

    MDR report key: 1905849 · Received November 18, 2010

    Report

    Report Number
    MW5018273
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    March 1, 2003
    Report Date
    November 1, 2010
    Product Code
    KOO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CAME OUT SIDES OF MOUTH WHILE EATING OR OTHER TIMES SWALLOWED AND MADE SICK TO STOMACH TO WHERE I COULDN'T WORK. HANDS, FEET, ARMS, LEGS WENT NUMB. STOMACH AND CHEST PAINS. IRRITATED GUM AND THROAT, CHEST, WEAKNESS IN HANDS AND FEET, LEGS, HIPS, PAIN AND GO NUMB. STARTED AFTER MY TEETH WERE DONE USED SUPER POLIGRIP AND FIXODENT. DOSE OR AMOUNT: DENTURE CREAM. FREQUENCY: 1-4 TIMES DAILY. ROUTE: ORAL. DATES OF USE: (B)(6) 2003 - STILL HAPPENING. DIAGNOSIS OR REASON FOR USE: DENTURE ADHESIVE CREAM. EVENT ABATED AFTER USE: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT FIXODENT KOO UNK
    2 POLIGRIP POLIGRIP KOL

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| S