BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTATRAK

    MDR report key: 144706 · Received January 15, 1998

    Report

    Report Number
    1225258-1998-00001
    Event Type
    Injury
    Date Received
    January 15, 1998
    Date of Event
    December 11, 1997
    Report Date
    December 18, 1997
    Manufacturer
    VISUALIZATION TECHNOLOGY, INC.
    Product Code
    LLZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN INACCURATE READING FROM THE DEVICE WAS ALLEGED TO HAVE BEEN THE CAUSE OF A CEREBRAL SPINAL FLUID LEAK EXPERIENCED DURING SINUS SURGERY NECESSITATING SURGICAL INTERVENTION. THE PT WAS ADMITTED TO THE HOSP FOR OBSERVATION AND DISCHARGED AFTER THREE DAYS WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTATRAK IMAGED GUIDED SURGERY DEVICE LLZ VISUALIZATION TECHNOLOGY, INC. 2000 MO *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R