BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN EXTERNAL DRAINAGE SYSTEM III

    MDR report key: 1842053 · Received September 21, 2010

    Report

    Report Number
    1226348-2010-00298
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    July 16, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC., MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K954021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE DEVICE HAD TO BE CHANGED SINCE THE PRESSURE WAS ACCUMULATING IN THE VALVE SYSTEM. THE DEVICE WAS TESTED DURING A BY-PASS METHOD AND A SATISFACTORY DRAINAGE WAS ACHIEVED. AS A RESULT, THE SURGEON WAS CONCERNED ABOUT AN INCREASE RISK OF CONTAMINATION.

    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., MEDOS S.A. NA CLFBVP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention