BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE

    MDR report key: 1140558 · Received August 28, 2008

    Report

    Report Number
    2023988-2008-00032
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTS THAT THE CATHETER WAS ZEROED PRIOR TO PLACEMENT, BUT THE VALUES OF THE CATHETER WERE NEVER DISPLAYED ON THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLM INTRACRANIAL PRESSURE NONE GWM INTEGRA NEUROSCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1