BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXODENT

    MDR report key: 1401633 · Received June 5, 2009

    Report

    Report Number
    MW5011435
    Event Type
    Injury
    Date Received
    June 5, 2009
    Date of Event
    March 1, 2003
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED FIXODENT FROM 1996 TO 2003 ON . THE SAME MONTH, I HAD A STROKE NUMBNESS AND TINGLING ON MY RIGHT SIDE. COULDN'T FEEL MY RIGHT ARM AND LEG. COULD NOT TALK OR EAT. I WENT TO MEDICAL CENTER. DOSE OR AMOUNT: 50 MG ON TEETH, 10 MG A DAY. NOT SURE OF DR'S NAME. FROM + CI + CARDIOVASCULAR SPECIALIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT NONE KOL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O| S