BEUDAMED
    FDA Adverse Event Death Summary report: N

    GE, SIEMENS AND HOLLOGIC MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM

    MDR report key: 23478326 · Received November 5, 2025

    Report

    Report Number
    MW5178531
    Event Type
    Death
    Date Received
    November 5, 2025
    Date of Event
    July 15, 2024
    Report Date
    October 22, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OTE
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOR ABDOMINAL PAIN ON (B)(6) 2024. IMAGING WAS CONCERNING FOR WIDELY METASTATIC DISEASE. PATIENT ADMITTED TO HOSPITAL FOR GI CONSULTATION ON (B)(6) 2024. DISCHARGED ON (B)(6) 2024. CT CAP AND NECK FROM (B)(6) 2024 DEMONSTRATED WIDESPREAD LYMPHADENOPATHY AND BONY METASTASES WITH ASCITES AND ABNORMAL APPEARANCE TO THE GALLBLADDER AS WELL AS EDEMATOUS APPEARANCE TO THE PANCREAS. MOST ACCESSIBLE AND LARGEST MASS WAS PRESENT IN THE LEFT SUPRACLAVICULAR AREA AND CASE WAS DISCUSSED WITH RADIOLOGY WHO RECOMMENDED TISSUE SAMPLING FROM THAT SITE. BIOPSY PERFORMED ON (B)(6) 2024, WHICH CONFIRMED STAGE IV CANCER WITH METASTASIS TO BONE AND LYMPH NODES. ONCOLOGY APPOINTMENT ON (B)(6) 2024, PATIENT OFFERED OPTIONS TO CONSIDER SUCH AS CHEMOTHERAPY TREATMENT AND NOT DOING FURTHER TREATMENT AND ENROLLING IN HOSPICE. HOSPICE OPTION WAS SELECTED ON (B)(6) 2024. ARRANGEMENTS WERE MADE AND SHE WAS DISCHARGED HOME TO BE PLACED ON HOSPICE. DEATH: (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2677950 GE, SIEMENS AND HOLLOGIC MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM DIGITAL BREAST TOMOSYNTHESIS OTE HOLOGIC, INC. SECURVIEW DX

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Hospitalization| D