BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIGRIP

    MDR report key: 1359016 · Received April 9, 2009

    Report

    Report Number
    MW5010703
    Event Type
    Injury
    Date Received
    April 9, 2009
    Date of Event
    January 1, 2006
    Report Date
    March 27, 2009
    Product Code
    KOL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED FIXODENT - 1997-2007. STOPPED-UNSATISFACTORY FOR HOLDING DENTURES. SWITCHED TO POLIDENT IN EARLY 2006. USED UNTIL 2008. SWITCHED TO SUPER-POLI GRIP AND/OR SUPER-POLIGRIP EXTRA CARE WITH POLYSEAL 2008 - EARLY 2009 - TRIED SEA BOND. DIDN'T LIKE. I BEGAN EXPERIENCING CHF AND CKF IN 2006? 2007? I ALSO DEVELOPED ANEMIA; APPROXIMATELY THIS TIME. IN 2007/2008, I DEVELOPED NUMBNESS, TINGLING, PAIN IN MY UPPER AND LOWER EXTREMITIES; ESPECIALLY LOWER MEDICATION GIVEN DID NOT ALLEVIATE. IN 2009, BLOOD SAMPLES INDICATED I HAD LOW NORMAL LEVEL OF COPPER AND HIGH LEVELS OF ZINC. MY NEUROPATHY/ANEMIA AND OTHER MEDICAL PROBLEM/DEMAND CONTINUED MEDICAL SERVICES. DOSE OR AMOUNT: DENTURE CREME. DENTURE CREAM. FREQUENCY: DAILY. ROUTE: 004. DATES OF USE: 2006 - 2009. DIAGNOSIS OR REASON FOR USE: 2006. 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 NONE KOL
    2 SUPER POLIGRIP SUPER POLIGRIP EXTRA CARE WITH POLYSEAL KOL

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| S