BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDS III CSF DRAIN SYS W/O V CATH

    MDR report key: 3132930 · Received May 29, 2013

    Report

    Report Number
    1226348-2013-17710
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 9, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK954021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE SALES REPORTED THAT THERE WERE 3 INCIDENTS WHERE THE TUBING CAME APART FROM THE CONNECTOR ON THE EDS3 PRODUCT. IN ALL 3 CASES, THE ENTIRE SYSTEM WAS REPLACED. THERE WERE 2 INCIDENTS WHERE THE TUBING CAME APART FROM THE STOPCOCK. BOTH OF THESE CASES ALSO REQUIRED REPLACEMENT OF THE EDS3 PRODUCT. NO ADVERSE CONSEQUENCES TO THE PATIENT WAS VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236684 EDS III CSF DRAIN SYS W/O V CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention