BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG STRL EVD SYSTEM (RAD)-NEW

    MDR report key: 1030382 · Received April 16, 2008

    Report

    Report Number
    2648988-2008-00018
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 16, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES, PR
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WAS REQUESTED FROM THE REPORTER BY TELEPHONE AND IN WRITING. NO ADD'L INFO IS AVAILABLE TO DATE. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THERE WAS A CRACK IN THE TUBING OF THE VENTRICULAR DRAINAGE SET. SOME CEREBROSPINAL FLUID LEAKAGE WAS OBSERVED. THE DEVICE WAS DISCARDED IN ERROR IN THE CLINICAL AREA. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKG STRL EVD SYSTEM (RAD)-NEW EXTERNAL DRAINAGE SYSTEM JXG INTEGRA NEUROSCIENCES, PR NL850-8300N

    Patients

    Seq Age Sex Outcome Treatment
    1