BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA CAMINO

    MDR report key: 1001419 · Received January 25, 2008

    Report

    Report Number
    1001419
    Event Type
    Malfunction
    Date Received
    January 25, 2008
    Date of Event
    January 17, 2008
    Report Date
    January 25, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    THE INTEGRA CAMINO VENTRICULAR BOLT PRESSURE MONITORING KIT WAS PACKED WITH WRONG DRILL BIT SIZE. A SECOND KIT WAS OPENED TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA CAMINO MONITORING KIT, INTRACRANIAL PRESSURE GWM INTEGRA NEUROSCIENCES 110-4H WO52012

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR