BEUDAMED
    FDA Adverse Event Summary report: N

    ESSURE

    MDR report key: 3101345 · Received May 3, 2013

    Report

    Report Number
    MW5030089
    Date Received
    May 3, 2013
    Date of Event
    February 25, 2013
    Report Date
    May 3, 2013
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM A MOTHER OF 3. MY LAST TWO PREGNANCIES WERE 2007 AND 2008. I DESIRED NO MORE CHILDREN. MY GYNO SUGGESTED THE IUD MIRENA. IT WAS UNSUCCESSFUL, SO THEY SUGGESTED ESSURE. I HAD THE COILS INSERTED IN 2010. FIRST 6 MONTHS WAS FINE. NORMAL PERIOD. EVEN LIGHT AT TIMES. BUT I STARTED TO FEEL LIKE I HAD THE FLU EVERYDAY AND I WAS BLEEDING THROUGH MY CLOTHES. CONSTANT HEADACHES. DEPRESSION INCREASED. WAS TOLD I HAD A HORMONE IMBALANCE. HAD AN ABLATION THE SUMMER OF 2011. ONE DAY SURGERY AT (B)(6) HOSPITAL. PERIODS WERE SOMEWHAT NORMAL FOR ABOUT 8 MONTHS. THEN THE SIDE EFFECTS MENTIONED PREVIOUSLY PROGRESSED. MY PERIODS WERE UNSTABLE AND HEAVY AND PUT ME IN THE BED. HOW CAN YOU BE A MOTHER, WIFE, EMPLOYEE WHEN YOU FEEL LIKE YOU ARE DYING?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195493 ESSURE ESSURE COILS HHS CONCEPTUS ESS305-R1 636097
    195581 ESSURE ESSURE COILS HHS CONCEPTUS ESS305-R1 12397881

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other