BEUDAMED
    FDA Adverse Event Death Summary report: N

    SELENIA DIMENSIONS DIGITAL MAMMOGRAPHY

    MDR report key: 19069903 · Received April 8, 2024

    Report

    Report Number
    MW5153638
    Event Type
    Death
    Date Received
    April 8, 2024
    Date of Event
    August 16, 2019
    Report Date
    April 4, 2024
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OTE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SUBJECT ENROLLED ON (B)(6) 2019, AND RANDOMIZED TO ARM A - BIENNIALLY. ON (B)(6) 2024, IT WAS DISCOVERED THAT SUBJECT #(B)(6) EXPIRED ON (B)(6) 2019. THIS DEATH OCCURRED LESS THAN 30 DAYS OF HER ENROLLMENT DATE, (B)(6) 2019. IT IS DOCUMENTED THAT SUBJECT WAS BROUGHT INTO THE ER (EMERGENCY ROOM) ON (B)(6) 2019, AFTER COMPLAINT OF SOB (SHORTNESS OF BREATH). UPON ARRIVAL OF EMS (EMERGENCY MEDICAL SERVICES), SUBJECT WAS FOUND UNRESPONSIVE AND RESUSCITATED AT 0600 (6:00AM). SUBJECT TRANSFERRED TO ER (EMERGENCY ROOM) AND SEEN BY PROVIDER AT 6:35AM. COMFORT MEASURES ORDERED. SUBJECT EXTUBATED WITH BRADYCARDIA, ASYSTOLE FOLLOWED. SUBJECT PRONOUNCED ON (B)(6) 2019 AT 1432 (2:32PM). ATTRIBUTED TO CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513593 SELENIA DIMENSIONS DIGITAL MAMMOGRAPHY DIGITAL BREAST TOMOSYNTHESIS OTE HOLOGIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Death| H