BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3881351 · Received June 18, 2014

    Report

    Report Number
    MW5036661
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SINCE HAVING THE ESSURE I'VE HAD EXTREME PERIODS. MISSING PERIODS. FIBROIDS, POLYPS, CYSTS, AND NOW ENDOMETRIAL HYPERPLASIA. WHICH WILL RESULT IN A HYSTERECTOMY SCHEDULED FOR (B)(6), 2014. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357313 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 30.000 YR Disability