BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-PRO II

    MDR report key: 2308999 · Received October 25, 2011

    Report

    Report Number
    2308999
    Event Type
    Malfunction
    Date Received
    October 25, 2011
    Date of Event
    October 6, 2011
    Report Date
    October 7, 2011
    Manufacturer
    CIVCO MEDICAL INSTRUMENTS CO., INC.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    RUBBER BAND THAT SECURES THE PROBE COVER BROKE AND FELL ONTO THE DRAPES. SURGEON STATES THIS IS THE 3RD ONE THAT HAS BROKEN, AND THE SECOND THIS WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-PRO II ULTRASOUND GUIDED NEEDLE COVER, SINGLE USE ITX CIVCO MEDICAL INSTRUMENTS CO., INC. * M748900

    Patients

    Seq Age Sex Outcome Treatment
    1 *