BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAINAGE SYSTEM

    MDR report key: 4093820 · Received September 16, 2014

    Report

    Report Number
    1226348-2014-11977
    Event Type
    Injury
    Date Received
    September 16, 2014
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    E-MAIL RECEIVED FROM THE SALES REP. INFORMED THAT: "SURGEON FOUND A RECURRING PROBLEM WITH THE CODMAN EDS3 EXTERNAL DRAINAGE SYSTEM THAT WE SUPPLY. HE STATES THAT THE SPECIMEN PORT LEAKS DURING ACCESS. SURGEON STATES THAT THIS HAS HAPPENED WITH AT LEAST 2 OF THESE PRODUCTS RECENTLY". SALES REP. HAS BEEN IN CONTACT WITH THE CUSTOMER IN ORDER TO OBTAIN MORE INFORMATION REGARDING THESE ISSUES. PLEASE ALSO SEE COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571541 DRAINAGE SYSTEM SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention