BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 2670164 · Received July 20, 2012

    Report

    Report Number
    2023988-2012-00029
    Event Type
    Malfunction
    Date Received
    July 20, 2012
    Report Date
    July 20, 2012
    Manufacturer
    INTEGRA NEURO SCIENCES CA/USA
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    AN OLM INTRACRANIAL PRESSURE MONITORING KIT WAS INVOLVED IN AN INCIDENT THAT WAS DESCRIBED AS FOLLOWS. THIS IS THE THIRD REPORT OF THREE. CROSS REF WITH MFR 2023988-2012-00026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLM INTRACRANIAL PRESSURE MONITORING KIT NA GWM INTEGRA NEURO SCIENCES CA/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention