BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 5655568 · Received May 16, 2016

    Report

    Report Number
    5655568
    Event Type
    Malfunction
    Date Received
    May 16, 2016
    Date of Event
    January 14, 2016
    Report Date
    May 6, 2016
    Manufacturer
    SUMMIT INDUSTRIES, LLC FORMERLY BENNETT X-RAY CORP.
    Product Code
    IZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE THE PATIENT WAS HAVING A MAMMO NEEDLE LOCALIZATION, THE MAMMO MACHINE WOULD NOT TAKE THE PICTURE. PATIENT WAS TAKEN TO THE BREAST CENTER FOR COMPLETION OF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312074 CONTOUR SYSTEM, X-RAY, MAMMOGRAPHIC IZH SUMMIT INDUSTRIES, LLC FORMERLY BENNETT X-RAY CORP. DM-1500

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR NO OTHER THERAPIES