BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTATRAK STRAIGHT ASPIRATOR

    MDR report key: 68102 · Received January 24, 1997

    Report

    Report Number
    53043-1997-00002
    Event Type
    Malfunction
    Date Received
    January 24, 1997
    Date of Event
    January 7, 1997
    Report Date
    January 7, 1997
    Manufacturer
    VISUALIZATION TECHNOLOGY INC.
    Product Code
    MGI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE ACCURACY WAS OFF BY SEVERAL MILLIMETERS DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTATRAK STRAIGHT ASPIRATOR ASPIRATOR/POINTER MGI VISUALIZATION TECHNOLOGY INC. NA JAZ6263-1

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other INSTATRAK SYSTEMS