BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4924407 · Received July 9, 2015

    Report

    Report Number
    MW5044398
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    September 25, 2014
    Report Date
    July 9, 2015
    Manufacturer
    BAYER CORP
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BEEN PUT ON THE ESSURE (B)(6) 2014. AND ABOUT 2 MONTH LATER THE PROBLEMS STARTED. SYMPTOMS: SURPRISINGLY PUNCHY PAIN, CRAMPING, SWELLING, BLEEDING. THE BIGGEST PROBLEM IS BLEEDING. BLEEDING WILL START THE NEXT DAY OR IN THE EVENING WHEN THERE IS SEX. THAT'S WHY I'M NOT HAD SEX WITH MY HUSBAND APPROX. 9 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447768 ESSURE PERMANENT BIRTH CONTROL HHS BAYER CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Disability