BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADDER CANCER

    MDR report key: 9197195 · Received October 15, 2019

    Report

    Report Number
    MW5090413
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    October 10, 2019
    Report Date
    October 11, 2019
    Manufacturer
    CARESONO TECHNOLOGY CO., LTD.
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MACHINE DOES NOT PRODUCE CONSISTENT RESULTS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983784 BLADDER CANCER SYSTEM, IMAGING, PULSED ECHIO, ULTRASONIC IYO CARESONO TECHNOLOGY CO., LTD. PADSCAN HD5

    Patients

    Seq Age Sex Outcome Treatment
    1