BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3892398 · Received June 24, 2014

    Report

    Report Number
    MW5036770
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY FIRST FEELING PAIN I THINK WAS IN (B)(6) 2012 I WAS HAVING BACK PAIN AND ABDOMINAL PAIN RUNNING FEVER. I WENT TO THE ER AND THEY FINALLY TOLD ME THAT I HAD A BAD BLADDER INFECTION AND MY WHITE CELL COUNT WAS LOW. WHEN I HAVE MY CYCLE I BLEED HEAVY AND CLOT BAD. I STILL HAVE ABDOMINAL AND BACK PAIN IN THE REGULAR. SINCE I GOT ESSURE MY URINE SMELL AWFUL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367608 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 32.000 YR Other