BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIONICS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM

    MDR report key: 469575 · Received June 27, 2003

    Report

    Report Number
    1222895-2003-00008
    Event Type
    Malfunction
    Date Received
    June 27, 2003
    Date of Event
    May 1, 2003
    Report Date
    May 28, 2003
    Manufacturer
    RADIONICS
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "THE USER FACILITY IS RETURNED THREE SETS DUE TO THE LEAKAGE AT THE THREE WAY STOP COCK. THE DEVICES WERE NOT USED ON PTS." - INCIDENT REPORT INTEGRA LIFE SCIENCES. THEY STATED THAT LEAKAGE WAS OBSERVED DURING A PRE-TEST/SETUP. THERE WAS NO PT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIONICS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM EXTERNAL DRAINAGE SYSTEM JXG RADIONICS ELDS-1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *