BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3881562 · Received June 18, 2014

    Report

    Report Number
    MW5036667
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    April 11, 2012
    Report Date
    June 7, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PROCEDURE COMPLETED IN (B)(6) OF 2011. ABOUT 6 MO. LATER BEGAN HAVING HORRIBLE BACK PAIN AND RIGHT HIP PAIN. EACH PERIOD REQUIRED CHANGE OF TAMPON HOURLY IF NOT SOONER DUE TO BLOODFLOW. JOINTS IN MY BODY HURT MORE THAN NORMAL AND PAIN BEGAN IN MY RIGHT UPPER ARM. I BEGAN GAINING WEIGHT AND ATTENDED (B)(6) TO TRY TO LOSE IT, RESULTING IN GAIN OF WEIGHING MORE THAN WHEN STARTED. I CONSULTED WITH MY OB-GYN AND WAS TOLD THE ESSURE DIDN'T CAUSE IT AND CAN NOT BE REMOVED BECAUSE ITS PERMANENT. SHE ADVISED AN ABLATION INSTEAD. I'VE BEEN TREATED FOR MENTAL HEALTH ISSUES MANY YEARS PRIOR TO PROCEDURE, DURING, AND CURRENTLY AS THAT HAS NOTHING TO DO WITH THESE SYMPTOMS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357106 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 46.000 YR Other WELLBUTRIN,LAMICTAL,TRILEPTAL,VYBRIID,AMBIEN,SYNTH