BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6135919 · Received November 30, 2016

    Report

    Report Number
    MW5066413
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    May 31, 2013
    Report Date
    November 29, 2016
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4) MY DEVICE WAS NOT PROVIDED WITH MY CURRENT INSURER. I AM WITH TWO AUTO IMMUNE DISEASES ONE BEING TREATED BY A HEMATOLOGIST WHICH IS SEVERE APLASTIC ANEMIA AND LUPUS WHICH IS BEING TREATED BY MY RHEUMATOLOGIST. BLOOD DISORDER NOT SURE HOW THAT CAME ABOUT. BUT I AM BEING TREATED WITH GENGRAF 600 MG A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786655 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 39.000 YR Hospitalization| L| O| S HEALTHY INDIVIDUAL