BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE COILS

    MDR report key: 3842892 · Received May 27, 2014

    Report

    Report Number
    MW5036371
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    March 4, 2011
    Report Date
    May 24, 2014
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I HAD THE ESSURE COILS PLACE AFTER THE BIRTH OF MY 4TH CHILD IN 2011, SINCE HAVING THE COILS PLACED I HAVE HAD SIGNIFICANT PELVIC PAINS, SEVERE MENSTRUAL CRAMPS, WEIGHT GAIN, RECURRENT PELVIC INFECTIONS, SWELLING AND INFLAMMATION IN MY PELVIC AREA AND ABDOMEN. I AM CURRENTLY IN THE PROCESS OF FINDING A OBGYN TO REMOVE THE ESSURE COILS AND ASSESS THE DAMAGE TO MY PELVIC REGION. I HAVE HAD 2 ULTRASOUNDS AND A CAT SCAN ALL DUE TO PELVIC PAIN. THIS DEVICE HAS COST ME THOUSANDS OF DOLLARS IN OFFICE VISITS, AND HAS GREATLY NEGATIVELY AFFECTED MY QUALITY OF LIFE. I HAVE PAIN DAILY, MY MARRIAGE HAS SUFFERED AS SEXUAL INTERCOURSE IS VERY PAINFUL, AND MY DESIRE FOR SEX HAS DROPPED DRAMATICALLY. I HAVE HAD TO CHANGE MY DIET TO HELP ALLEVIATE SOME OF THE INFLAMMATION BUT NOTHING TRULY RIDS ME OF THE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310015 ESSURE COILS ESSURE COILS HHS

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention| S