BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VENTRICULAR & PERITONEAL CATHETER WITH BACTISEAL

    MDR report key: 1212609 · Received October 24, 2008

    Report

    Report Number
    1226348-2008-00285
    Event Type
    Injury
    Date Received
    October 24, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC./MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K003322
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 REPORTED THAT CSF WAS CULTURED AND THERE DOES NOT APPEAR TO BE AN INFECTION, HOWEVER, THE PATHOLOGY REPORT INDICATED THAT THERE WAS AN INFECTION BASED ON A HIGH WHITE BLOOD CELL COUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM VENTRICULAR & PERITONEAL CATHETER WITH BACTISEAL SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC./MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention