BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3892058 · Received June 24, 2014

    Report

    Report Number
    MW5036768
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 11, 2011
    Report Date
    June 19, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HEAVY BLEEDING, EXTREME PAIN IN PELVIC REGION, RASH, FATIGUE, BLOATING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368644 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 29.000 YR Other