BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHPV, CYLINDRICAL VALVE WITH U

    MDR report key: 2251867 · Received September 16, 2011

    Report

    Report Number
    1226348-2011-00352
    Event Type
    Injury
    Date Received
    September 16, 2011
    Manufacturer
    CODMAN AND SHURTLEFF - RAYNHAM
    Product Code
    JXG
    PMA / PMN Number
    K020667
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THIS COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE WAS VISUALLY AND FUNCTIONALLY TESTED AND WAS FOUND TO WORK IN ACCORDANCE WITH THE MANUFACTURING SPECIFICATIONS. THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTIONS. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. 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 VALVE HAD TO BE EXPLANTED BECAUSE IT STOPPED FUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHPV, CYLINDRICAL VALVE WITH U SHUNT, CENTRAL NERVOUS SYSTEM COMPS JXG CODMAN AND SHURTLEFF - RAYNHAM 439274

    Patients

    Seq Age Sex Outcome Treatment
    1