BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROG VALVE, RT ANGLE RES. SEPARABLE

    MDR report key: 2050931 · Received April 4, 2011

    Report

    Report Number
    1226348-2011-00120
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    March 2, 2011
    Manufacturer
    CODMAN AND SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    K992173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT CLEAR AT THIS POINT IF THE DEVICE AND/OR LOT INFORMATION IS AVAILABLE. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF THE DEVICE IS RETURNED THE COMPLAINT WILL BE INVESTIGATED AND A FOLLOW UP REPORT WILL BE FILED. IF LOT INFORMATION DOES BECOMES AVAILABLE AND IF THE RECORD REVIEW INDICATES THAT THERE WAS A NON-CONFORMITY A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    REP REPORTED THAT IT WAS DISCOVERED THAT THE CODMAN VALVE WAS NOT DRAINING. FLOW WAS OBSERVED WITH THE VENTRICULAR CATHETER AND A MANOMETER WAS USED TO TEST THE DISTAL CATHETER WHICH WAS PATENT. A MANOMETER WAS USED TO TEST THE VALVE AND FLOW WAS NOT OBSERVED. THE VALVE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROG VALVE, RT ANGLE RES. SEPARABLE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPS JXG CODMAN AND SHURTLEFF, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention