BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3881323 · Received June 18, 2014

    Report

    Report Number
    MW5036660
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    June 14, 2013
    Report Date
    May 30, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS TOLD THAT IT WAS SHOWN ON THE XRAY THAT MY LEFT SIDE COIL HAD RIPPED THROUGH MY FALLOPIAN TUBE AND IS LODGED HALF IN AND HALF OUT OF MY UTERUS. SINCE HAVING THE ESSURE INSERTED I GET FREQUENT HEADACHES (WHICH I USED TO RARELY GET) AND AT TIMES I HAVE MEASURING FROM MILD, TO INTENSE CRAMPS/PAIN ON THE LEFT SIDE AROUND MY MENSTRUAL CYCLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357020 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 26.000 YR Other NONE, EXCEPT IBUPROPHEN WHEN I HAVE A HEADACHE