BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3131154 · Received May 17, 2013

    Report

    Report Number
    MW5030277
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    October 2, 2007
    Report Date
    May 15, 2013
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COILS WERE IMPLANTED TO PREVENT PREGNANCIES. I WAS TOLD THERE WERE NO COMPLICATIONS ASSOCIATED WITH THESE COILS. I SUFFER FROM SEVERE DEBILITATING CRAMPS, PAIN AND PAINFUL INTERCOURSE. THE COILS HAVE MIGRATED FROM THE IMPLANTED POSITION TO FURTHER INTO MY FALLOPIAN TUBES. SINCE IMPLANTATION I'VE HAD HEAVY MENSTRUAL BLEEDING AND LARGE CLOTS. I NEVER EXPERIENCED ANY OF THESE SIDE EFFECTS PRIOR TO HAVING ESSURE IMPLANTED. MEDWATCH #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219824 ESSURE COIL HHS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| O