BEUDAMED
    FDA Adverse Event Death Summary report: N

    INDURA

    MDR report key: 686308 · Received March 10, 2006

    Report

    Report Number
    6000030-2006-00422
    Event Type
    Death
    Date Received
    March 10, 2006
    Date of Event
    February 8, 2006
    Report Date
    February 10, 2006
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    BSO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD EXPIRED WITHIN 24 HOURS OF SURGERY. THE PATIENT HAD UNDERGONE REVISION OF THE DISTAL PORTION OF THE CATHETER DUE TO MIGRATION OUT OF THE INTRATHECAL SPACE. IT IS UNKNOWN WHAT SYMPTOMS THE PATIENT WAS EXPERIENCING OR IF ANY TROUBLESHOOTING WAS PERFORMED PRIOR TO SURGERY. THE PATIENT WAS RECEIVING DILAUDID, BUT THE CONCENTRATION AND DAILY DOSE ARE UNKNOWN. THE CATHETER WAS PRIMED; AN ADDITIONAL THERAPEUTIC BOLUS WAS NOT GIVEN. THE PATIENT WAS " A REALLY SICK GUY" WITH CO-MORBIDITIES INCLUDING RESPIRATORY PROBLEMS. THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND EXPIRED BETWEEN 3 AND 5 AM OF "ASPIRATION". IT IS UNKNOWN IF ANY AUTOPSY WAS PERFORMED. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE MANUFACTURER'S REPRESENTATIVE AND THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA CATHETER BSO RICE CREEK MANUFACTURING UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death