BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

    MDR report key: 3901117 · Received June 30, 2014

    Report

    Report Number
    1226348-2014-11777
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 20, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK954021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. COMPLAINT SAMPLE NOT RETURNED.

    Description of Event or Problem · 1

    E-MAIL RECEIVED FROM THE SALES REP. INFORMED THAT: "DURING A VENTRICULOSTOMY, THE PRODUCT TUBING CAME UNDONE AT THE BASE OF EDS3. THEY RECONNECTED THE TUBING TO THE EDS 3 AND KEPT IT ON THE PATIENT". NOTE THAT COMPLAINT SAMPLE WILL NOT BE RETURNED FOR EVALUATION, AND PRODUCT LOT NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379331 EXT DRAINAGE SYSTEM III WITHOUT VENT CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention