BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 424449 · Received October 24, 2002

    Report

    Report Number
    2023988-2002-00067
    Event Type
    Malfunction
    Date Received
    October 24, 2002
    Date of Event
    August 1, 2002
    Report Date
    October 24, 2002
    Manufacturer
    INTEGRA NEUROCARE LLC
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE PT TRIPPED AND FELL CAUSING RIGHT ACUTE SUBDURAL, MIDLINE SHIFT AND EDEMA. EVACUATION OF SUBDURAL AND INSERTION OF CAMINO CATHETER WAS PERFORMED. THE ICP REMAINED NORMAL SUBSEQUENTLY. THE CAMINO CATHETER WAS REMOVED IN AUGUST 2002 AND KEPT FOR ANALYSIS BUT THE TIP HAS BEEN SENT FOR CULTURE. ADDITIONAL INFO WAS RECEIVED ON 10-02-2002. THE CATHETER HAS BEEN IDENTIFIED AS 110-4BT. THE LOT NUMBER PROVIDED W034-010-013 WAS IDENTIFIED FOR THE CONNECTOR USED WITH THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRACRANIAL PRESSURE MONITORING KIT CAMINO PRESSURE MONITORING CATHETER KITS GWM INTEGRA NEUROCARE LLC * W035009

    Patients

    Seq Age Sex Outcome Treatment
    1 *