BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5105031 · Received September 25, 2015

    Report

    Report Number
    MW5056510
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    March 22, 2013
    Report Date
    September 24, 2015
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). MY ESSURE WAS COVERED BY MY INSURANCE PROVIDER, (B)(6) WITH THE EXCEPTION OF MY CO-PAY. I HAD THE PROCEDURE FOR IMPLANTING ON (B)(6) 2013. AFTER THE 3 MONTH WAITING PERIOD, I HAD THE HSG TEST DONE BY (B)(6), AND WAS TOLD THAT ONE COIL WAS PROPERLY PLACE BUT THE OTHER HAD MIGRATED. A LATER MRI REVEALED THE COIL WAS OUTSIDE THE FALLOPIAN TUBE. I WAS GIVEN THE CHOICE TO INSERT A THIRD COIL OR CHOOSE A DIFFERENT BIRTH CONTROL METHOD, SUCH AS THE PILL. AFTER LITTLE CONSIDERATION, I ASKED TO HAVE BOTH COILS REMOVED IN (B)(6) 2013. REMOVAL WAS ALSO COVERED BY INSURANCE WITH THE EXCEPTION OF MY CO-PAY. DURING THE TIME IN WHICH I HAD ESSURE IN MY BODY, I REPORTED TO MY PHYSICIAN VIA EMAIL THROUGH THE (B)(6) THE EXTREME PAIN, HEAVY BLOOD FLOW DURING MENSTRUAL CYCLE, BLOATING AND WEIGHT GAIN, AND OTHER GENERAL SYMPTOMS THAT WERE TOLERABLE, BUT PRESENT ONLY AFTER ESSURE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634940 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 39.000 YR