BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUJIFILM DOUBLE BALLOON ENDOSCOPE, EN-450T5, EN450P5

    MDR report key: 17802719 · Received September 22, 2023

    Report

    Report Number
    1000513161-2023-00067
    Event Type
    Death
    Date Received
    September 22, 2023
    Report Date
    September 22, 2023
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ON 8/17/2023, FUJIFILM CORPORATION BECAME AWARE OF LITERATURE INVOLING EN-450T5 AND EN-450P5. UPON REVIEWING LITERATURE, ONE PROCEDURE RELATED DEATH WAS REPORTED. THE EXACT DATE OF THE EVENTS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880692 FUJIFILM DOUBLE BALLOON ENDOSCOPE, EN-450T5, EN450P5 ENTEROSCOPE AND ACCESSORIES FDA FUJIFILM CORPORATION EN-450T5, EN-450P5 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R| O| D