BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAMMOGRAPHIC TOMOSYNTHETIS SYSTEM

    MDR report key: 18058264 · Received November 1, 2023

    Report

    Report Number
    MW5147647
    Event Type
    Death
    Date Received
    November 1, 2023
    Date of Event
    May 15, 2023
    Report Date
    October 31, 2023
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MUE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TOMOSYNTHESIS MAMMOGRAPHIC IMAGING SCREENING TRIAL (TMIST). T4 SCREENING MAMMOGRAM COMPLETED ON (B)(6) 2023. FOLLOW-UP PHONE CALL PLACED ON (B)(6) 2023 MESSAGE LEFT TO RETURN CALL IF ANY COMPLICATIONS WERE EXPERIENCED DUE TO MAMMOGRAM. PATIENT DUE FOR 5-YEAR FOLLOW-UP (B)(6) 2023. CHECKED PATIENT'S EMR FOR FOLLOW-UP. NOTED PATIENT EXPIRED ON (B)(6) 2023 WHICH IS SIX DAYS POST MAMMOGRAM. CAUSE OF DEATH NOTED ON DEATH CERTIFICATE ATHEROSCLEROTIC HEART DISEASE (CARDIAC ARREST). EXPEDITED REPORT FILED PER PROTOCOL - OVERRIDE FUNCTION COMPLETED TO REPORT. START DATE OF FIRST COURSE: (B)(6) 2023. START DATE OF COURSE ASSOCIATED WITH EXPEDITED REPORT: (B)(6) 2023. START DATE OF PRIMARY AE: (B)(6) 2023. END DATE OF PRIMARY AE: (B)(6) 2023. COURSE NUMBER ON WHICH EVENT(S) OCCURRED: (B)(4). TOTAL NUMBER OF COURSES TO DATE: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON NOVEMBER 2, 20023 FOR REPORT NUMBER MW5147647. BASELINE T0 SCREENING COMPLETED ON (B)(6) 2018. NO CALL BACK RECEIVED. NOTED PT EXPIRED ON (B)(6) 2023 WHICH IS SIX DAYS POST T4 MAMMOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154491 MAMMOGRAPHIC TOMOSYNTHETIS SYSTEM FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC MUE HOLOGIC, INC. ASY04160

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Death