BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA LIFE SCIENCES

    MDR report key: 1247084 · Received November 21, 2008

    Report

    Report Number
    1247084
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 30, 2008
    Manufacturer
    INTEGRA LIFE SCIENCES
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    PATIENT'S EXTERNAL SHUNT WAS DISCONNECTED. NP HAD JUST APPLIED A NEW EXTERNAL SHUNT SYSTEM ON THE PATIENT. THE ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM FROM INTEGRA LIFE SCIENCES HAD MALFUNCTIONED BY THE SQUEEZE-LOK TAB AND WAS NOT ADJUSTABLE FOR LEVELING TO PT. NP HAD TO REPLACE THE SYSTEM ONE MORE TIME AND PT WAS NOT HAPPY. THE MANUFACTURER WAS NOTIFIED AND PROVIDED REPLACEMENT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA LIFE SCIENCES SHUNT, CENTRAL NERVOUS SYSTEM JXG INTEGRA LIFE SCIENCES * 1081778

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO