BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD PRESSURE MONITOR

    MDR report key: 19710706 · Received July 10, 2024

    Report

    Report Number
    3011196194-2024-00030
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    June 21, 2024
    Report Date
    July 10, 2024
    Manufacturer
    TELADOC 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 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 THE BLOOD PRESSURE CUFF BECAME TIGHT AROUND THEIR ARM CAUSING BRUISES. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PATIENT TO DETERMINE IF THE PATIENT RECEIVED ANY MEDICAL ATTENTION AND/OR TREATMENT FOR THE REPORTED BRUISES BUT WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144403 LIVONGO BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN TELADOC HEALTH, INC. HT900

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Unknown Other