BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3893828 · Received June 18, 2014

    Report

    Report Number
    MW5036782
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    December 23, 2009
    Report Date
    June 17, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ESSURE DEVICE IMPLANTED 2006 IS CAUSING, TO MYSELF, SEVERAL HEALTH CONDITIONS. EXTREME MENSTRUAL CYCLES WITH CRAMPS, GETTING LOW RANGE IN THE HEMOGLOBIN. UNBELIEVABLE PAINS ALL AROUND MY BODY ESPECIALLY THE ABDOMEN AND THE BACK, CHRONIC MIGRAINES, FIBROMYALGIA, INFLAMMATORY ARTHRITIS, LOSS OF HAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358926 ESSURE ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Disability