BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD PRESSURE MONITOR

    MDR report key: 16230184 · Received January 23, 2023

    Report

    Report Number
    3011196194-2023-00003
    Event Type
    Injury
    Date Received
    January 23, 2023
    Date of Event
    December 29, 2022
    Report Date
    January 23, 2023
    Manufacturer
    LIVONGO HEALTH INC
    Product Code
    DXN
    PMA / PMN Number
    K131395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IF THE DEVICE IS RETURNED AN INVESTIGATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED. THIS REPORT IS BEING FILED DUE TO THE PATIENT REPORTING SCARRING CAUSED BY USE OF THE LIVONGO BLOOD PRESSURE MONITOR.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT USE OF THE LIVONGO BLOOD PRESSURE MONITOR RESULTED IN SCARRING ON THEIR ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617171 LIVONGO BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN LIVONGO HEALTH INC HT900

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown Disability