BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROVISION CI

    MDR report key: 272559 · Received March 31, 2000

    Report

    Report Number
    1063474-2000-00001
    Event Type
    Malfunction
    Date Received
    March 31, 2000
    Date of Event
    February 21, 2000
    Report Date
    March 31, 2000
    Manufacturer
    AGFA CORP.
    Product Code
    IWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FILM REPORTEDLY EXHIBITED LOW DENSITY ARTIFACTS WHICH SUPPOSEDLY COULD RESEMBLE MICRO-CALCIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROVISION CI RADIOGRAPHIC FILM IWZ AGFA CORP. 592 9091-0341-04, 9081-0584-01

    Patients

    Seq Age Sex Outcome Treatment
    1 *