BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VENTRICULAR & PERITONEAL CATHETERS WITH BACTISEAL

    MDR report key: 2933650 · Received January 29, 2013

    Report

    Report Number
    1226348-2013-11604
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    December 18, 2012
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    PK003322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED - HAKIM PROGRAMMABLE VALVES AND BACTISEAL SHUNT CATHETERS REMOVED DUE TO INFECTION. VERY VAGUE DETAILS SUPPLIED BY CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39187 HAKIM VENTRICULAR & PERITONEAL CATHETERS WITH BACTISEAL SHUNT, CENTRAL NERVOUS SYS & COMPS JXG CODMAN & SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention