BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAYER HEALTHCARE, LLC

    MDR report key: 3966531 · Received July 14, 2014

    Report

    Report Number
    MW5037485
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BAXTER HEALTHCARE, LLC
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IMPLANT WAS GETTING STUCK ON SHEATH OF HYSTEROSCOPE, BENDING THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410055 BAYER HEALTHCARE, LLC ESSURE DEVICE HHS BAXTER HEALTHCARE, LLC ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR