BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLIGRIP REGULAR

    MDR report key: 1861368 · Received October 5, 2010

    Report

    Report Number
    MW5017686
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 26, 2010
    Product Code
    KOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HEART DAMAGE. TINGLING IN ALL MY LIMBS. SWELLING ANKLES. HANDS AND FEET. NUMBNESS OF THE BODY. HIGH BLOOD SINCE (B)(6) 2009. PAIN ALL OVER MY BODY. DOSE OR AMOUNT: POLIGRIP. FREQUENCY: TWICE DAILY. ROUTE: ORAL. DATES OF USE: 2008 - 2010 (B)(6). 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 POLIGRIP REGULAR NONE KOL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other