BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THD EVOLUTION

    MDR report key: 3811948 · Received April 30, 2014

    Report

    Report Number
    3811948
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 30, 2014
    Manufacturer
    THD AMERICA, INC.
    Product Code
    JAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS NO SOUND FROM THE DOPPLER MACHINE. DEVICE WAS TURNED ON AND OFF A FEW TIMES, BUT STILL DID NOT SOUND PROPERLY; A NEW PRODUCT WAS OPENED AND WORKED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258631 THD EVOLUTION TRANSANAL HEMMORIDAL DOPPLER JAF THD AMERICA, INC. * ZO46247

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR