BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD PRESSURE MONITOR

    MDR report key: 16686696 · Received April 5, 2023

    Report

    Report Number
    3011196194-2023-00034
    Event Type
    Injury
    Date Received
    April 5, 2023
    Date of Event
    March 11, 2023
    Report Date
    April 5, 2023
    Manufacturer
    LIVONGO HEALTH, INC.
    Product Code
    DXN
    PMA / PMN Number
    K131395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE BLOOD PRESSURE MONITOR WAS REQUESTED BACK FROM THE PATIENT BUT HAS NOT YET 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

    PATIENT REPORTED THE LIVONGO BLOOD PRESSURE MONITOR CUFF CAUSED THEM PAIN AND CUT OFF CIRCULATION ON THEIR ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755980 LIVONGO BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN LIVONGO HEALTH, INC. HT900

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Other