BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3913281 · Received June 30, 2014

    Report

    Report Number
    MW5037039
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE ESSURE HAS CAUSED PELVIC PAIN AND BACK PAIN, A METALLIC TASE IN MY MOUTH AND VERY HEAVY MENSTRUAL CYCLE. NOW NEED TO HAVE A HYSTERECTOMY FOR REMOVAL THAT IS SCHEDULED FOR (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378901 ESSURE NONE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR