BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXADENT DENTURE ADHESIVE

    MDR report key: 1346826 · Received March 18, 2009

    Report

    Report Number
    MW5010392
    Event Type
    Injury
    Date Received
    March 18, 2009
    Date of Event
    February 3, 2009
    Report Date
    March 18, 2009
    Manufacturer
    PROCTOR & GAMBLE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BAD LEGS THAT CAME ON TO ME QUITE SUDDENLY, ON VACATION. I WAS FEELING GOOD UNTIL ON THAT SUNDAY, STARTED CRAMPING IN LEGS, WHEN I WAS MOVING. I COULD SIT AND NOTHING HAPPENED AT ALL, BUT THE MINUTE I STOOD, I FELT AS IF I WAS FALLING DOWN, IF I DIDN'T GRAB ONTO A CHAIR OR SOMETHING. I WENT TO THE EMERGENCY ROOM AND THEY THOUGHT IT WAS A BLOOD CLOT, SO DID AN ULTRA-SOUND. THAT CAME BACK GOOD, SO THEY GAVE ME PAIN PILLS & MUSCLE RELAXERS, AND THAT DIDN'T SEEM TO WORK AND GETTING WORSE, SO BACK TO HOSPITAL, AND THEY DID AN MRI, FINDING BULGING 4 & 5 DISCS, SO THEY PUT ME ON PREDNISONE, AND I LEFT FOR HOME, BACK TO NY. I WENT TO MY DR. AND HE TOOK ME OFF THE PREDNISONE, TO SEE IF IT GOT BETTER. I EVEN WENT TO A BACK SPECIALIST AND HE ADVISED GOING TO THERAPY, WHICH I HAVE BEEN DOING TWICE A WEEK FOR A MONTH. IT DOESN'T SEEM TO BE GETTING ANY BETTER AND I CAME ACROSS A WARNING ON THE INTERNET ABOUT A PRODUCT, WHICH MY HUSBAND AND I DO USE ALMOST EVERY DAY. THAT PRODUCT IS FIXADENT DENTURE ADHESIVE, AND THE SYMPTOMS MATCH MINE TO THE LETTER. I THOUGH YOU SHOULD KNOW AND TO INFORM OTHERS OF THIS PRODUCT BEING NOT WHAT IT SEEMS. I WILL BE HAVING A BLOOD TEST TO DETERMINE, IF THERE IS EXCESSIVE ZINC OR COPPER IN MY BLOOD, PRAYING THAT I AM WRONG, AND FEELING BETTER SOON. FREQUENCY: EVERYDAY. DIAGNOSIS: HOLD DENTURES IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXADENT DENTURE ADHESIVE NONE KOL PROCTOR & GAMBLE

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| S