BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTATRAK ASPIRATOR

    MDR report key: 79017 · Received February 18, 1997

    Report

    Report Number
    1225258-1997-00003
    Event Type
    Malfunction
    Date Received
    February 18, 1997
    Date of Event
    February 12, 1997
    Report Date
    February 12, 1997
    Manufacturer
    VISUALIZATION TECHNOLOGY INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE ACCURACY WAS OFF BY 1 CM. DURING USE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other INSTATRAK SYSTEM