BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN EXTERNAL DRAINAGE SYSTEM III

    MDR report key: 2191245 · Received July 29, 2011

    Report

    Report Number
    1226348-2011-00284
    Event Type
    Injury
    Date Received
    July 29, 2011
    Report Date
    July 1, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC. MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K954021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFO IS NOT AVAILABLE FOR EVAL. WITHOUT THE DEVICE AND/OR LOT INFO, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFO 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.

    Description of Event or Problem · 1

    SALES REP REPORTED THAT THE DRAIN CAME APART AT THE PT STOP COCK. IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT NUMBER IS NOT AVAILABLE. ALTHOUGH LEAKAGE WAS NOT REPORTED IT IS POSSIBLE THAT THERE MAY HAVE BEEN LEAKAGE. AS A CONSERVATIVE MEASURE A REPORT IS BEING GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN EXTERNAL DRAINAGE SYSTEM III SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK