BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 MHZ MICRO DISPOSABLE DOPPLER PROBE

    MDR report key: 12049465 · Received June 22, 2021

    Report

    Report Number
    MW5102019
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    June 16, 2021
    Report Date
    June 17, 2021
    Manufacturer
    MIZUHO MEDICAL INNOVATION / VASCULAR TECHNOLOGY INCORPORATED
    Product Code
    DPW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A 20 MHZ MICRO DISPOSABLE DOPPLER PROBE DID NOT WORK. REPLACED WITH "LIKE" DEVICE FROM ANOTHER LOT WHICH FUNCTIONED WITHOUT ISSUE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935742 20 MHZ MICRO DISPOSABLE DOPPLER PROBE FLOWMETER, BLOOD, CARDIOVASCULAR DPW MIZUHO MEDICAL INNOVATION / VASCULAR TECHNOLOGY INCORPORATED 07-150-12 (10)17128

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR