BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD PRESSURE MONITOR

    MDR report key: 16540563 · Received March 14, 2023

    Report

    Report Number
    3011196194-2023-00020
    Event Type
    Injury
    Date Received
    March 14, 2023
    Date of Event
    February 17, 2023
    Report Date
    March 13, 2023
    Manufacturer
    LIVONGO 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE BLOOD PRESSURE MONITOR WAS REQUESTED BACK FROM THE PATIENT BUT HAS NOT YET BEEN DELIVERED TO THE MANUFACTURER. WHEN THE DEVICE IS DELIVERED 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 SQUEEZES THEIR ARM TOO TIGHT CAUSING BRUISING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934396 LIVONGO BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN LIVONGO HEALTH, INC. HT900

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown Other