BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEMOTO DUAL SHOT ALP

    MDR report key: 10484755 · Received September 2, 2020

    Report

    Report Number
    2126677-2020-00007
    Event Type
    Injury
    Date Received
    September 2, 2020
    Date of Event
    July 31, 2020
    Report Date
    November 6, 2020
    Manufacturer
    NEMOTO KYORINDO CO., LTD.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A CT SCAN, THE PATIENT STARTED TO COMPLAIN FOR CHEST PAIN, CAUSED BY AIR EMBOLISM. CUSTOMER DESCRIBED IT AS A MASSIVE AMOUNT OF AIR. THE PATIENT WAS NOT SHOWING ANY OTHER SYMPTOMS AND WAS HOSPITALIZED FOR OBSERVATION.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE MANUFACTURERS INVESTIGATION. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DURING A CT SCAN, A PATIENT MAY HAVE EXPERIENCED AN AIR EMBOLISM THROUGH USE OF A CONTRAST INJECTOR. NO PROBLEMS WITH THE EQUIPMENT WERE REPORTED. THE PATIENT WAS NOT SHOWING ANY OTHER SYMPTOMS AND WAS HOSPITALIZED FOR OBSERVATION UNTIL STABILIZED. THIS PRODUCT IS NOT MANUFACTURED BY GE HEALTHCARE. GE HEALTHCARE IS THE IMPORTER OF THE NEMOTO INJECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948393 NEMOTO DUAL SHOT ALP INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT NEMOTO KYORINDO CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR