BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3910676 · Received July 2, 2014

    Report

    Report Number
    MW5037009
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 29, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SEVERE CRAMPING ALL THE TIME EVER SINCE THE ESSURE WAS DONE IN 2012. HEADACHES, BLOATING, CRAMPING, BLEEDING, MISSED PERIODS, RASHES, DEPRESSION, CYST ON OVARIES, BRUISES FOR NO REASON, BACK PAIN ALL THE TIME, UTIS ALL THE TIME. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387222 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 28.000 YR Other OMEPRAZOLE