BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOMOSPOT

    MDR report key: 9330391 · Received November 15, 2019

    Report

    Report Number
    9021987-2019-00004
    Event Type
    Injury
    Date Received
    November 15, 2019
    Date of Event
    October 29, 2019
    Report Date
    November 15, 2019
    Manufacturer
    BEEKLEY CORPORATION
    Product Code
    JAC
    UDI-DI
    00815137020513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TOMOSPOT LOT 784.05231801 WAS PART OF RECALL 9021987-6/14/18-001-R.

    Description of Event or Problem · 1

    A PALPABLE MASS MARKER CAUSED ARTIFACT ON A MAMMOGRAM. AS A RESULT, THE MAMMOGRAM WAS REPEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124771 TOMOSPOT PALPABLE MASS MARKER JAC BEEKLEY CORPORATION 784 784.05231801 00815137020513

    Patients

    Seq Age Sex Outcome Treatment
    1 Other