BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD PRESSURE MONITOR

    MDR report key: 16219121 · Received January 20, 2023

    Report

    Report Number
    3011196194-2023-00002
    Event Type
    Injury
    Date Received
    January 20, 2023
    Date of Event
    December 21, 2022
    Report Date
    January 20, 2023
    Manufacturer
    LIVONGO HEALTH INC
    Product Code
    DXN
    PMA / PMN Number
    K131395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BLOOD PRESSURE MONITOR WAS REQUESTED FROM THE PATIENT BUT HAS NOT BEEN RETURNED. IF THE DEVICE IS RETURNED AN INVESTIGATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED. THIS REPORT IS BEING FILED DUE OT THE PATIENT EXPERIENCING PAIN IN THEIR ARM FROM THE LIVONGO BLOOD PRESSURE MONITOR CUFF INFLATING AND RESULTING IN ECCHYMOSIS.

    Description of Event or Problem · 0

    THE MEMBER REPORTED THAT WHILE USING THEIR LIVONGO BLOOD PRESSURE MONITOR THE MONITOR BECAME TOO TIGHT AND LEFT A CONTUSION ON THEIR ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1984609 LIVONGO BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN LIVONGO HEALTH INC HT900

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Unknown Other