BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTREGRA LIFE SCIENCES

    MDR report key: 1247083 · Received November 21, 2008

    Report

    Report Number
    1247083
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 28, 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 HAD AN INTEGRA DISPOSABLE LP DRAIN IN PLACE. WHEN PATIENT ARRIVED FROM PICU, THE ADMITTING NURSE WAS UNABLE TO CHANGE THE LEVEL OF THE LP DRAIN. THE MOVEABLE PIECE TO SET THE LEVEL AT CM OF H20 WAS STUCK AT THE TOP OF THE DRAINAGE SYSTEM. PHYSICIAN CHANGED THE ENTIRE DRAINAGE SYSTEM WITHOUT INCIDENT. THE MANUFACTURER HAS SINCE PROVIDED REPLACEMENT PARTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR