BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9591301 · Received January 14, 2020

    Report

    Report Number
    MW5092220
    Event Type
    Injury
    Date Received
    January 14, 2020
    Date of Event
    February 1, 2010
    Report Date
    January 12, 2020
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS IMPLANTED IN 2008. I SLOWLY STARTED TO FEEL ABDOMINAL PAIN AND HAD WORSENING PERIODS. AFTER A FEW YEARS MY PERIODS WERE AWFUL. HEAVY BLEEDING FOR SEVERAL DAYS. VERY LARGE CLOTS. MIGRAINES OFTEN. THEN MY BODY STARTED TO SWELL. I HAD SEVERE INFLAMMATION. EVERYWHERE, I WENT TO SEVERAL DRS BUT NO ONE HELPED ME. I LOST MANY DAYS OF WORK. I LOST JOBS BECAUSE I WAS NOT ABLE OF WORK. I STARTED TO GET RASHES THAT WOULD COME AND GO. I HAD A HYSTERECTOMY IN (B)(6) 2019. AFTER THAT MY SYMPTOMS SLOWLY WENT AWAY. I STILL HAVE VERY MUCH HAIR LOSS AND OCCASIONAL MIGRAINES. BUT I FEEL MUCH MORE HUMAN. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52108 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER HEALTHCARE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| O ENBREL | IBUPROFEN