BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSOUND F-75

    MDR report key: 13687871 · Received March 8, 2022

    Report

    Report Number
    1528028-2022-00011
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    April 8, 2021
    Report Date
    March 7, 2022
    Manufacturer
    FUJIFILM HEALTHCARE CORPORATION
    Product Code
    IYN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2021, FUJIFILM HEALTHCARE AMERICAS CORPORATION (FORMERLY HITACHI HEALTHCARE AMERICAS CORPORATION) RECEIVED A COMPLAINT REGARDING PROSOUND F-75. THE SITE REPORTED TO OLYMPUS THAT THEY WERE COMPLETING A PROCEDURE ON (B)(6) 2021 WHEN THEY NOTICED VERY GRAINY IMAGES. THE DOCTOR WAS UNABLE TO MAKE OUT CLEAR VISUALS AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS UNDER ANESTHESIA WHEN THE PROCEDURE (EGD/EUS) WAS CANCELLED. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH EVENT. DURING A RETROSPECTIVE REVIEW, IT WAS DISCOVERED THAT THE MANUFACTURER HAD ASSESSED THIS EVENT AS AE LEADING TO SERIOUS INJURY; THEREFORE AN IMPORTER'S MDR IS BEING SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655489 PROSOUND F-75 PROSOUND F-75. IYN FUJIFILM HEALTHCARE CORPORATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other