BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A-SPOT

    MDR report key: 3946268 · Received July 3, 2014

    Report

    Report Number
    9021987-2014-00007
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 4, 2014
    Report Date
    July 1, 2014
    Manufacturer
    BEEKLEY MEDICAL
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PALPABLE MASS MARKER NOT IMAGING WELL ON MAMMOGRAM, RESULTING IN A REPEAT MAMMOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389078 A-SPOT PALPABALE MASS MARKER KGX BEEKLEY MEDICAL 751 751312141102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other