BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

    MDR report key: 3140509 · Received May 31, 2013

    Report

    Report Number
    1226348-2013-17954
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 15, 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 REP REPORTED THAT THE EDS3 TUBING BECAME DISCONNECTED. A COUPLE OF HOURS LATER, THE TUBING CAME APART AT THE STOPCOCK ON A DRAIN. AS A RESULT, THE SYSTEM WAS DISCARDED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240853 EXT DRAINAGE SYSTEM III WITHOUT VENT CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention