BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN LUMBAR EXTERNAL DRAINAGE KIT

    MDR report key: 3121849 · Received May 21, 2013

    Report

    Report Number
    1226348-2013-17429
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 25, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IN ABSENCE OF THE DEVICE A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THE DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. IF THE DEVICE DOES GET RETURNED IN THE FUTURE THE COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. BASED ON THE RESULTS OF THIS INVESTIGATION, NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT UPON REMOVAL OF THE DRAINS, EACH OF THE DRAINS BROKE INSIDE THE PATIENT. AS A RESULT, THE DEVICE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224608 CODMAN LUMBAR EXTERNAL DRAINAGE KIT CNS EXTERNAL DRAINAGE SYSTEM JXG CODMAN & SHURTLEFF, INC. CNPCBF

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention