BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO BLOOD PRESSURE MONITOR

    MDR report key: 20034776 · Received August 22, 2024

    Report

    Report Number
    3011196194-2024-00043
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 25, 2024
    Report Date
    August 17, 2024
    Manufacturer
    TELADOC HEALTH, INC.
    Product Code
    DXN
    PMA / PMN Number
    K170196
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE ASSOCIATED WITH THIS INCIDENT WAS NOT RETURNED FOR INVESTIGATION. SHOULD THIS DEVICE BE RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED TO DOCUMENT THE RESULTS OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT THE BLOOD PRESSURE CUFF INFLATED TO OVER 250 MMHG, WAS PAINFUL, AND CAUSED BRUISING, AND NUMBNESS. THE NUMBNESS PERSISTED FOR ABOUT 10 MINUTES. THE PATIENT ALSO REPORTED THEY EXPERIENCED PETECHIAE. THE PATIENT DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26731 LIVONGO BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN TELADOC HEALTH, INC. UA-651BLE-LIV

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Other