BEUDAMED
    FDA Adverse Event Summary report: N

    CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM 1.9MM

    MDR report key: 3727766 · Received March 27, 2014

    Report

    Report Number
    MW5035465
    Date Received
    March 27, 2014
    Date of Event
    February 27, 2014
    Report Date
    March 19, 2014
    Manufacturer
    CODMAN AND SHURTLEFF, INC.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EVD CATHETER INSERTED (B)(6) 2014 FOR TREATMENT OF ICN AFTER MVA. ON (B)(6) 2014: EVD REMOVED. ON (B)(6) 2014: PT HAD ALTERED MENTAL STATUS. LUMBAR PUNCTURE WITH CSF SPECIMEN OBTAINED. ON (B)(6) 2014: CSF CULTURE GREW SERRATIA MARCESENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179890 CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM 1.9MM EDS JXG CODMAN AND SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention