BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENSHI DIAGNOSTIC ULTRASOUND FF-SONIC UF-4500

    MDR report key: 137188 · Received June 18, 1997

    Report

    Report Number
    MW4002078
    Event Type
    Malfunction
    Date Received
    June 18, 1997
    Report Date
    June 18, 1997
    Manufacturer
    FUKUDA DENSHI USA, INC.
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COMPLAINT IS A CHIROPRACTOR WHO PURCHASED A DIAGNOSTIC ULTRASOUND UNIT WHICH WAS REPRESENTED AS BEING SUITABLE FOR USE IN DIAGNOSING SPINAL CONDITIONS. THE UNIT, ACCORDING TO THE COMPLAINT, WAS NOT ONLY UNSUITABLE FOR THE TASK BUT ALSO UNAPPROVED FOR THAT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENSHI DIAGNOSTIC ULTRASOUND FF-SONIC UF-4500 PULSED ECHO IMAGING SYSTEM IYO FUKUDA DENSHI USA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA