BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOGUARD COVER

    MDR report key: 6543763 · Received May 4, 2017

    Report

    Report Number
    1937223-2017-00001
    Event Type
    Malfunction
    Date Received
    May 4, 2017
    Date of Event
    December 2, 2016
    Report Date
    January 2, 2017
    Manufacturer
    CIVCO MEDICAL INSTRUMENTS CO., INC
    Product Code
    ITX
    PMA / PMN Number
    K013721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED, HOWEVER PHOTO'S OF THE COVER AND PROBE WERE PROVIDED. FROM THE PHOTOGRAPHS SHOWN, THE PROBE HAS A METALIC CYLINDRICAL END WHICH WAS WHICH THE USER WAS ABLE TO PUSH THROUGH THE TIP OF THE COVER CUTTING A CIRCULAR HOLE IN THE COVER ITSELF. THIS IS A RE-SUBMISSION OF THE REPORT CONDUCTED ON 1/2/2017. ORIGINAL SUBMISSION HAD INCORRECT FACILITY IDENTIFICATION NUMBER AND WAS REJECTED.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A MASTECTOMY / BIOPSY SENTILE NODE OF THE LEFT BREAST. WHEN THE PROBE WAS PLACED ON THE STERILE BACK TABLE, IT WAS NOTED THAT THE TIP OF THE PROBE (NODE SEEKER) HAD PENETRATED THROUGH THE TRANSDUCER COVER. A SMALL ROUND PIECE OF THE TRANSDUCER COVER WAS LATER RECOVERED ON THE STERILE MAYOSTAND. THE STERILE FIELD WAS TAKEN DOWN, THA PATIENT WAS RE-PREPPED AND SURGERY WAS CONTINUED WITH A NEW DRAPING AND INSTRUMENTS. SURGICAL SITE WAS 2X IRRIGATED WITH NS BEFORE CLOSURE. NO PATIENT INJURES OR PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325187 NEOGUARD COVER ULTRASOUND COVER ITX CIVCO MEDICAL INSTRUMENTS CO., INC 610-844 M745600

    Patients

    Seq Age Sex Outcome Treatment
    1