BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3910535 · Received July 2, 2014

    Report

    Report Number
    MW5036998
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    February 21, 2010
    Report Date
    June 28, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS IMPLANTED WITH ESSURE. THIS IS MANUFACTURED BY BAYER , FORMERLY CONCEPTUS. I HAVE SEEN DR. (B)(6) MY IMPLANTING DR. HE DOESN'T LISTEN TO MY COMPLAINTS . I AM LOOKING FOR ANOTHER DR. I HAVE HAD SEVERE WEIGHT GAIN. VITAMIN D DEFICIENCY, BLOATING IN THE ABDOMEN AND PELVIS AREA. I HAVE ABNORMAL SHARP PAINS IN THE AREA OF IMPLANT, PAINFUL INTERCOURSE, IRREGULAR PERIODS, IRREGULAR BOWEL MOVEMENTS, FLUTTERING MOVEMENTS IN THE AREA OF THE COILS. THIS HAS BEEN STEADY FOR THE PAST FEW YEARS, I STILL HAVE THE DEVICE INSIDE ME. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388056 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 40.000 YR Other