BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3793015 · Received April 30, 2014

    Report

    Report Number
    MW5035907
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    April 29, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE ESSURE PROCEDURE DONE IN 2010. I NOW SUFFER FROM HEADACHE, BLURRED VISION, ABDOMINAL PAIN, HIP PAIN, BACK PAIN, DEPRESSION. I WAS DIAGNOSED WITH INFLAMMATION OF THE CERVIX AND OVARIES A WEEK AGO, AND AN NOW ON 2-500MG ANTIBIOTICS TWICE A DAY PLUS HYDROCODONE FOR PAIN. I GO BACK TO MY OB-GYN AT THE END OF THE MONTH FOR MORE TESTS. I HAVE NOT HAD ANY PREVIOUS MEDICAL ISSUES. I USED TO BE ABLE TO ENJOY HIKING AND MANY OTHER OUTDOOR ACTIVITIES AND NOW HAVE TO FORCE MYSELF OUT OF BED EVERY MORNING BECAUSE I AM SO FATIGUED. I HAVE NO CYSTS AND WAS NOT ON BIRTH CONTROL PRIOR TO HAVING THE PROCEDURE DONE. I WILL BE MORE THAN HAPPY TO PROVIDE MY F/U APPOINTMENT FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259849 ESSURE ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR