BEUDAMED
    FDA Adverse Event Death Summary report: N

    GE, SIEMENS AND HOLOGIC

    MDR report key: 11421152 · Received March 4, 2021

    Report

    Report Number
    MW5099787
    Event Type
    Death
    Date Received
    March 4, 2021
    Date of Event
    December 31, 2018
    Report Date
    February 25, 2021
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OTE
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT ENROLLED ON (B)(6) AND COMPLETED TIME 1 BREAST MRI (B)(6) 2017. WHEN CONTACTED FOR SCHEDULING HER TIME 2 BREAST MRI IN (B)(6) 2018, PATIENT SHARED SHE HAD BEEN DIAGNOSED WITH URETHRAL CANCER AND WITHDREW FROM STUDY PARTICIPATION BUT AGREED TO FOLLOW-UP WITH STUDY TEAM. STUDY TEAM WAS NOTIFIED BY PATIENT'S SPOUSE THAT SHE PASSED AWAY IN (B)(6) 2018 FROM DISEASE PROGRESSION AFTER PATIENT DISCONTINUED THERAPY IN (B)(6) 2018 BUT TEAM WAS UNABLE TO GET AN EXACT DATE OF DEATH. ON (B)(6) 2018 IS PROVIDED AS AN APPROXIMATE DATE OF DEATH FOR THIS SUBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311806 GE, SIEMENS AND HOLOGIC DIGITAL BREAST TOMOSYNTHESIS OTE HOLOGIC, INC. SELENIA DIMENSIONS 8000 TOMO

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| H