BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3781232 · Received April 30, 2014

    Report

    Report Number
    MW5035812
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    September 1, 2009
    Report Date
    April 22, 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 A MEDICAL DEVICE IMPLANT CALLED ESSURE IN 2008. THIS MEDICAL DEVICE IMPLANT IS NOW MANUFACTURED BY BAYER, FORMALLY BY CONCEPTUS INC. THIS DEVICE HAS A THREE YEAR SHELF LIFE, HOWEVER, I DO NOT HAVE THAT EXPIRATION DATE. THE ONSET OF MY COMPLAINT STARTED IN (B)(6) 2009. THIS IS A LIST OF MY SIDE EFFECTS AND SYMPTOMS THAT I HAVE EXPERIENCED DUE TO ESSURE. EXTREME AND CHRONIC ABDOMINAL PAINS, IRREGULAR PERIODS, BLEEDING, SPOTTING, INFLAMMATION LEADING TO CONSTIPATION AND HEMORRHOIDS. NUMEROUS VISITS TO THE ER, A COLORECTAL SURGERY DUE TO ABSCESS, HEADACHES, EXTREME FATIGUE, CONFUSION, LACK OF CLARITY AND CONCENTRATION, DEPRESSION, WEIGHT GAIN, INABILITY TO LOSE WEIGHT AND MIGRAINES. I HAVE BEEN SEEN BY AT LEAST 7 DIFFERENT NUMBER OF DOCTORS. I HAVE BEEN DIAGNOSED WITH THE FOLLOWING CONDITIONS IBS, RLS, OVARIAN CYSTS, DEPRESSION AND MIGRAINES. THE DEVICE IS STILL INSIDE OF ME. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259264 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 35.000 YR Hospitalization| O| S ESSURE