BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LORAD MULTICARE PLATINUM

    MDR report key: 2043250 · Received March 31, 2011

    Report

    Report Number
    2043250
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 31, 2011
    Manufacturer
    HOLOGIC, INC.
    Product Code
    IZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    PER THE PHYSICIAN, THE STEREOTACTIC BREAST BIOPSY EQUIPMENT DIDN'T PROPERLY TARGET THE AREA OF CONCERN. THE PHYSICIAN SAID THAT ALL OF THE CALCIFICATIONS WERE NOT CAPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LORAD MULTICARE PLATINUM STEREOTACTIC BREAST BIOPSY SYSTEM IZH HOLOGIC, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR