BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD PRESSURE MONITOR

    MDR report key: 19929783 · Received August 7, 2024

    Report

    Report Number
    3011196194-2024-00041
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    July 22, 2024
    Report Date
    August 6, 2024
    Manufacturer
    TELADOC HEALTH, INC.
    Product Code
    DXN
    PMA / PMN Number
    K131395
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT WAS SENT A REPLACEMENT MONITOR. THE MONITOR ASSICIATED WITH THIS FILING WAS REQUESTED BACK FOR INVESTIGATION. THE DEVICE WAS NOT RETURNED. SHOULD THE DEVICE BE RETURNED AT A LATER DATE, A SUPPLIMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE PATIENT STATED THAT WHILE USING THE LIVONGO BLOOD PRESSURE MONITOR, THE CUFF CONTINUED TO INFLATE LEAVING BRUISES ON THEIR ARM. THE PATIENT ALSO STATED THE MONITOR HAD TO BE UNPLUGGED FOR THE CUFF TO STOP INFLATING, THE MONITOR DID NOT RESPOND TO THE POWER BUTTON. THE PATIENT CONFIRMED NO MEDICAL ATTENTION AND/OR TREATMENT WAS PROVIDED DUE TO THE BRUISING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263619 LIVONGO BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN TELADOC HEALTH, INC. HT945

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown Other