BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIGRIP

    MDR report key: 1893101 · Received November 2, 2010

    Report

    Report Number
    MW5018045
    Event Type
    Injury
    Date Received
    November 2, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED POLIGRIP FROM APPROXIMATELY (B)(6) 1988 UNTIL (B)(6) 2010. WHILE I WAS USING THE PRODUCT, I BEGAN EXPERIENCING NUMBNESS AND TINGLING IN MY EXTREMITIES. ABOUT (B)(6) 2010, I WAS DIAGNOSED WITH NEUROPATHY. BLOOD TEST TAKEN AT THE TIME SHOWED THAT ZINC AND COPPER LEVELS HAD BEEN OMITTED ALONG WITH THE HIGH AND LOW RANGE COUNTS. MY NEUROPATHY IS PERMANENT AND REQUIRES CONTINUED MEDICAL CARE AND TREATMENT. POSSIBLY EVEN MY DEATH. LOSS OF BALANCE; HANDS AND FEET ALWAYS NUMB AND TINGLY; (LIKE SOMEONE HAS TOUCHED A LINE OF LIVE WIRE AND THEN TOUCHED ME) EXTREME WEAKNESS; (CAN BARELY LIFT A GALLON OF MILK), LOSING THE ABILITY TO FOCUS MY EYES. WEAR ADULT DIAPERS NOW AND CAN'T WALK VERY WELL, BECAUSE IT'S HARD TO SUPPORT MY OWN WEIGHT. DOSE OR AMOUNT: DENTURE CREAM. FREQUENCY: DAILY. ROUTE: ORAL. DATES OF USE: (B)(6) 1988 - (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 POLIGRIP SUPER KOL GLAXOSMITHKLINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| S