BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACRANIAL PRESSURE MONITORING KIT 110-AB

    MDR report key: 508767 · Received January 9, 2004

    Report

    Report Number
    2023988-2004-00003
    Event Type
    Malfunction
    Date Received
    January 9, 2004
    Report Date
    January 7, 2004
    Manufacturer
    INTEGRA NEUROCARE LLC
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SURGEON INSERTED THE CATHETER INTO THE PT AND LEFT IN PLACE. THE MONITOR READING WAS -30MMHG. THE SURGEON REMOVED THE CATHETER AND PLACED HIS FINGER ON THE TIP OF THE CATHETER BUT THE READING WAS STILL LESS THAN ZERO. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRACRANIAL PRESSURE MONITORING KIT 110-AB NEURO MONITORING GWM INTEGRA NEUROCARE LLC * W041042

    Patients

    Seq Age Sex Outcome Treatment
    1 *