BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4883825 · Received July 1, 2015

    Report

    Report Number
    MW5043393
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    November 1, 2009
    Report Date
    May 17, 2015
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). MENORRHAGIA, NICKEL ALLERGY, ALLERGIC REACTIONS, PRURITIS, ABLATION, HYSTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425019 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 0.000 YR Required Intervention