BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5881890 · Received August 12, 2016

    Report

    Report Number
    MW5064115
    Event Type
    Injury
    Date Received
    August 12, 2016
    Date of Event
    May 1, 2014
    Report Date
    August 12, 2016
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE ESSURE PLACED IN 2013, INITIALLY NO COMPLICATIONS, HOWEVER; SINCE THE PROCEDURE I HAVE EXPERIENCED CHRONIC LLQ ABDOMINAL PAIN, IRREGULAR BLEEDING AND SPOTTING REQUIRING BIRTH CONTROL PILLS ALONG WITH PASSING LARGE CLOTS. I AM SCHEDULED FOR A HYSTERECTOMY LATER THIS YEAR TO HAVE THIS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523263 ESSURE PERMANENT BIRTH CONTROL HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention