BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD EDS SET OF SIX

    MDR report key: 510955 · Received January 14, 2004

    Report

    Report Number
    9612007-2004-00003
    Event Type
    Malfunction
    Date Received
    January 14, 2004
    Report Date
    January 14, 2004
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE ANTI-REFLUX BALL WAS STUCK. THIS WAS NOTED WHEN INSTALLING THE DEVICE. THE SET WAS CHANGED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD EDS SET OF SIX EXTERNAL DRAINAGE SYSTEM JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. * 60300370

    Patients

    Seq Age Sex Outcome Treatment
    1 *