BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACRANIAL PRESSURE/TEMPERATURE MONITORING K

    MDR report key: 1886309 · Received October 18, 2010

    Report

    Report Number
    2023988-2010-00035
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES SD
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF FOUR REPORTS INVOLVING AN INTRACRANIAL PRESSURE/TEMPERATURE MONITORING KIT (1104BT) WITH THE SAME PRODUCT PROBLEM FROM THE SAME FACILITY BUT DIFFERENT PATIENTS. IT WAS INITIALLY REPORTED ON (B)(6) 2010 THAT THE CATHETER PULLS OUT OF THE BOLT WITH LITTLE EFFORT. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. ON (B)(4) 2010, THE CUSTOMER REPORTED THAT THE CATHETER WAS REVISED AND REPLACED. ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED BUT NOT OTHER INFORMATION WAS PROVIDED. CROSS REFERENCED TO MANUFACTURER REPORT NUMBERS: 2023988-2010-00036, 2023988-2010-00037, AND 2023988-2010-00034.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRACRANIAL PRESSURE/TEMPERATURE MONITORING K NA GWM INTEGRA NEUROSCIENCES SD 305000187031

    Patients

    Seq Age Sex Outcome Treatment
    1