BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 3820088 · Received May 16, 2014

    Report

    Report Number
    3820088
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 16, 2014
    Manufacturer
    BAYER HEALTHCARE, LLC.
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ESSURE DEVICE WAS INSERTED THROUGH THE OPERATING CHANNEL OF THE HYSTEROSCOPE. THE LEFT OSTIA WAS VISUALIZED AND BASED ON MANUFACTURER RECOMMENDATIONS, THE DEVICE WAS DEPLOYED. IN A SIMILAR FASHION, THE RIGHT OSTIA WAS VISUALIZED AND BASED ON MANUFACTURER RECOMMENDATIONS, THE DEVICE WAS DEPLOYED. THE DEVICE DID NOT DEPLOY AS EXPECTED; HOWEVER THE COILS INSERTED WERE WITHIN THE NORMAL PARAMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294638 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER HEALTHCARE, LLC. ESS305 B26272

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR