BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIGRIP - SUPER STRONG

    MDR report key: 1658769 · Received April 12, 2010

    Report

    Report Number
    MW5015528
    Event Type
    Injury
    Date Received
    April 12, 2010
    Date of Event
    March 28, 2009
    Report Date
    February 28, 2010
    Product Code
    KOQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE USED POLIGRIP AND MY HAND START TINGLING AND NUMBNESS FROM MY LEFT ARM DOWN TO MY FINGER. BUT I WENT TO THE DOCTOR AND THEY COULD NOT FIND ANYTHING. AND THEN MY HEART STARTING BEATING FAST WHEN I LAY DOWN TO SLEEP AND I HAVE TO GET UP FOR A WHILE. DOSE OR AMOUNT: 2 DOSES A DAY, FREQUENCY: EVERYDAY. DIAGNOSIS OR REASON FOR USE: DENTURE. EVENT ABATED AFTER USE: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIGRIP - SUPER STRONG SUPER STRONG KOQ

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other