BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD PRESSURE MONITOR

    MDR report key: 16513299 · Received March 9, 2023

    Report

    Report Number
    3011196194-2023-00017
    Event Type
    Injury
    Date Received
    March 9, 2023
    Date of Event
    February 22, 2023
    Report Date
    March 9, 2023
    Manufacturer
    LIVONGO HEALTH, INC.
    Product Code
    DXN
    PMA / PMN Number
    K131395
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT STATED THE BLOOD PRESSURE CUFF WAS TOO TIGHT AND CAUSED PAIN.

    Description of Event or Problem · 0

    THE PATIENT STATED THE CUFF WAS VERY TIGHT AND THAT HER ARM HURT FOR A FEW DAYS AFTER TAKING THE BLOOD PRESSURE READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626880 LIVONGO BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN LIVONGO HEALTH, INC. HT900

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female