BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACRANIAL PRESSURE MONITORING KIT 110-4B

    MDR report key: 508764 · Received January 9, 2004

    Report

    Report Number
    2023988-2004-00004
    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 CLAIMS THAT AFTER SURGERY THE DOCTOR INSERTED AND PLACED THE CATHETER ON THE PT. HOWEVER, THE MEASURING VALUE DRIFT AND DID NOT BECOME STEADY. THE PROBLEM WAS SOLVED WITH REPLACING THE CATHETER. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRACRANIAL PRESSURE MONITORING KIT 110-4B NEURO MONITORING GWM INTEGRA NEUROCARE LLC * W038066

    Patients

    Seq Age Sex Outcome Treatment
    1 *