BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN EXTERNAL DRAINAGE SYSTEM III

    MDR report key: 1961027 · Received January 11, 2011

    Report

    Report Number
    1226348-2011-00007
    Event Type
    Injury
    Date Received
    January 11, 2011
    Report Date
    December 16, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    K954021
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    REP REPORTS THAT THE (B)(4) CSF TUBING SEPARATED FROM THE Y-CONNECTOR DURING USE. THE SYSTEM WAS IN PLACE AND WORKING FINE. WHEN THE PATIENT WAS POSITIONED THE LINE SEPARATED. IT WAS NOTICED IMMEDIATELY AND THE SYSTEM WAS CHANGED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN EXTERNAL DRAINAGE SYSTEM III SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC NA CLHCCO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK