BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT SCAN

    MDR report key: 9166703 · Received October 7, 2019

    Report

    Report Number
    MW5090260
    Event Type
    Injury
    Date Received
    October 7, 2019
    Date of Event
    September 15, 2019
    Report Date
    October 3, 2019
    Manufacturer
    NEUSOFT MEDICAL SYSTEMS CO., LTD.
    Product Code
    JAK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THORACIC CT SCAN THE RUBBER RING IN THE MYLAR FELT DOWN AND CAUSE INJURY TO THE PT. PT PRESENT MODERATED LACERATIONS IN THE RIGHT FOOT PROVOKED OPEN WOUNDS AND SEVERAL ABRASIONS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957318 CT SCAN SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK NEUSOFT MEDICAL SYSTEMS CO., LTD. NEUSOFT / NEUVIZ 64 IN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other