BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-IV MAMMOGRAPHY SYSTEM

    MDR report key: 263266 · Received February 14, 2000

    Report

    Report Number
    1220984-2000-00002
    Event Type
    Malfunction
    Date Received
    February 14, 2000
    Date of Event
    December 1, 1999
    Report Date
    February 14, 2000
    Manufacturer
    TREX MEDICAL SYSTEMS CORP
    Product Code
    IZH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STEREOLOC II PROCEDURE, THE NEEDLE WENT BEYOND THE LESION AND STRUCK THE BREAST PLATFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M-IV MAMMOGRAPHY SYSTEM RADIOLOGIC IZH TREX MEDICAL SYSTEMS CORP M-IV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN