BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3963550 · Received July 24, 2014

    Report

    Report Number
    MW5037462
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    October 1, 2012
    Report Date
    July 24, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED ESSURE IMPLANT DEVICES IN MY FALLOPIAN TUBES IN (B)(6) 2012. I AM NOW EXPERIENCING SEVERE PELVIC PAIN AND INFLAMMATION IN THE EXACT LOCATION OF THE INSERTS, AND STABBING PELVIC PAIN ON THE LEFT SIDE. I WILL SEE MY GYNECOLOGIST ABOUT ESSURE REMOVAL ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434866 ESSURE ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention| S