BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORONARY CT ANGIOGRAPHY

    MDR report key: 20089018 · Received August 27, 2024

    Report

    Report Number
    MW5158904
    Event Type
    Injury
    Date Received
    August 27, 2024
    Report Date
    August 28, 2024
    Manufacturer
    CARISTO DIAGNOSTICS
    Product Code
    LLZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CARISTO HAS SHOWN EXAMPLES OF ADVERSE CARDIOVASCULAR EVENTS EVEN IN NORMAL CORONARY ARTERIES BY CORONARY CT ANGIOGRAPHY, AS PART OF THEIR REGISTRIES. THIS CAN BE VERY CONCERNING FOR THE PATIENT AND REFERRING PHYSICIANS, CAN CAUSE PANIC. COMPANY WEBSITE: WWW.CARISTO.COM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198648 CORONARY CT ANGIOGRAPHY SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ CARISTO DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown