BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3910673 · Received July 2, 2014

    Report

    Report Number
    MW5037008
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    August 22, 2013
    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

    I STARTED EXPERIENCING EXCRUCIATING PAIN TO MY LEFT LOWER ABDOMEN AND PELVIC AREA. IT FELT LIKE SEVERE CRAMPS WHICH I HAVE NEVER IN MY ENTIRE LIFE HAD EXPERIENCED. I WAS ORDERED BLOOD WORK AND A ULTRASOUND WHICH REVEALED I HAD A HEMORRHAGIC CYST. I CONTINUED TO HAVE MORE PAIN THROUGHOUT THE MONTHS, FOLLOWED UP WITH MORE ULTRASOUNDS AND CT SCANS. THEN THE FIRST WEEK OF DECEMBER MY GYNECOLOGIST DID A HYSTEROSCOPE ON ME AND TOOK OUT ONE OF THE ESSURE COILS OUT OF ME VAGINALLY ON THE LEFT SIDE ONLY AND UNDER NO ANESTHESIA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387221 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TAMOXIFEN CITRATE 20 MG