BEUDAMED
    FDA Adverse Event Summary report: N

    MIV MAMMOGRAPHY SYSTEM

    MDR report key: 5759429 · Received June 29, 2016

    Report

    Report Number
    1220894-2016-00021
    Date Received
    June 29, 2016
    Date of Event
    June 1, 2016
    Report Date
    June 29, 2016
    Manufacturer
    HOLOGIC, INC.
    Product Code
    IZH
    PMA / PMN Number
    KO11987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ON GOING.

    Description of Event or Problem · 1

    SCREWS ON RAILS OF LINEAR MOTION GUIDE WERE TORN AND THE RAILS DROPPED OFF ON M-IV

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413629 MIV MAMMOGRAPHY SYSTEM MAMMOGRAPHY SYSTEM IZH HOLOGIC, INC. M4-00001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1