BEUDAMED
    FDA Adverse Event Death Summary report: N

    GE, SIEMENS AND HOLOGIC MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM

    MDR report key: 20663153 · Received November 8, 2024

    Report

    Report Number
    MW5162325
    Event Type
    Death
    Date Received
    November 8, 2024
    Date of Event
    September 13, 2019
    Report Date
    October 30, 2024
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OTE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    UPON COMPLETING FOLLOW UP REPORTING, IT WAS DISCOVERED THAT SUBJECT (B)(6) EXPIRED ON (B)(6) 2019, WITHIN 30 DAYS OF HER ENROLLMENT DATE (B)(6) 2019. THE DEATH WAS REPORTED BY A FRIEND/FAMILY MEMBER DURING A FOLLOW UP PHONE CALL TO SCHEDULE AN APPOINTMENT. THE DATE OF DEATH WAS CONFIRMED ON LEGACY.COM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514450 GE, SIEMENS AND HOLOGIC MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM DIGITAL BREAST TOMOSYNTHESIS OTE HOLOGIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Death| H