BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACRANIAL PRESSURE / TEMPERATURE MONITORING K

    MDR report key: 1934751 · Received November 29, 2010

    Report

    Report Number
    2023988-2010-00043
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Report Date
    November 29, 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 EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE CATHETER SLIPPED OUT OF THE BOLT FROM AN INTRACRANIAL PRESSURE / TEMPERATURE MONITORING KIT THAT WAS IN CONTACT WITH A PATIENT. THERE WAS NO INJURY INVOLVED WITH THIS INCIDENT. ADD'L CLINICAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRACRANIAL PRESSURE / TEMPERATURE MONITORING K NA GWM INTEGRA NEUROSCIENCES SD POSSIBLY 305000189860

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR