BEUDAMED
    FDA Adverse Event Summary report: N

    CODMAN EXTERNAL DRAINAGE SYSTEM III

    MDR report key: 1221664 · Received November 5, 2008

    Report

    Report Number
    1226348-2008-00298
    Date Received
    November 5, 2008
    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
    MD, 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

    THE SALES REP REPORTED THAT THE EDSIII DRAINAGE SYSTEM WAS HOOKED UP TO THE PATIENT AND WHILE TAKING A CSF SAMPLE ON DAYS 3, 4 AND 5, THE CLINICIAN NOTED THAT AIR WAS BEING TRAPPED IN THE SYSTEM. WHEN AIR WAS OBSERVED IN THE SYSTEM, THE RESIDENT LOWERED THE DRAIN IN AN ATTEMPT TO RELEASE THE AIR. WHEN THE DRAIN WAS LIFTED UP AGAIN, AIR BECAME TRAPPED AGAIN. IN ADDITION, THE REP EXPLAINED THAT A CT SCAN CONFIRMED PHUMANACYPALIS, (AIR ON THE BRAIN).

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention