BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD PRESSURE MONITOR

    MDR report key: 20128494 · Received September 3, 2024

    Report

    Report Number
    3011196194-2024-00045
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    August 6, 2024
    Report Date
    August 22, 2024
    Manufacturer
    TELADOC HEALTH, INC.
    Product Code
    DXN
    PMA / PMN Number
    K202891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BLOOD PRESSURE MONITOR ASSOCIATED WITH THIS REPORT WAS REQUESTED BACK BUT HAS NOT BEEN RETURNED. IF THE DEVICE IS RETURNED AN INVESTIGATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT THEIR CUFF CONTINUED TO INFLATE TO THE POINT OF BRUISING THEIR ARM. TELADOC'S BLOOD PRESSURE MONITOR FITS PATIENTS WITH UP TO A 45CM ARM CIRCUMFERENCE, THE PATIENT CONFIRMED THAT THEIR ARM DOES NOT FALL IN THE CUFF RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105135 LIVONGO BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN TELADOC HEALTH, INC. HT945

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Unknown Other