BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACRANIAL KIT 110-4BT

    MDR report key: 1202191 · Received October 16, 2008

    Report

    Report Number
    2023988-2008-00038
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Report Date
    October 15, 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 REPORT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    AS REPORTED BY THE DISTRIBUTOR. A NEW CATHETER WAS USED TO REPLACE THE FAULTY CATHETER. WHEN THE ORIGINAL CATHETER WAS CONNECTED TO THE MONITORING DEVICE, THE ICP (INTRACRANIAL PRESSURE) READING WAS NORMAL, BUT THE TEMPERATURE READING DID NOT DISPLAY A NUMBER FOR THE TEMPERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRACRANIAL KIT 110-4BT ICP DISPOSABLES GWM INTEGRA NEUROSCIENCES 110-4BT

    Patients

    Seq Age Sex Outcome Treatment
    1