BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 8054089 · Received November 8, 2018

    Report

    Report Number
    3005798905-2018-02743
    Event Type
    Malfunction
    Date Received
    November 8, 2018
    Date of Event
    October 8, 2018
    Report Date
    November 8, 2018
    Manufacturer
    MHC MEDICAL PRODCUTS, LLC.
    Product Code
    DXN
    PMA / PMN Number
    K091415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    KEEPS GIVING HIGH READINGS. RESULTED IN A HOSPITAL VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893654 EASYTOUCH BLOOD PRESSURE MONITOR DXN MHC MEDICAL PRODCUTS, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization