BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDEX¿ BPM SMART BLOOD PRESSURE MONITOR

    MDR report key: 20822479 · Received November 29, 2024

    Report

    Report Number
    MW5163037
    Event Type
    Injury
    Date Received
    November 29, 2024
    Date of Event
    November 23, 2024
    Report Date
    November 23, 2024
    Manufacturer
    YA HORNG ELECTRONIC CO., LTD.
    Product Code
    DXN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WHEN I USED THE GARMIN INDEX BPM BLOOD PRESSURE MONITOR DEVICE, IT SQUEEZED MY ARM VERY HARD. IT LEFT MY LEFT ARM WITH SKIN IRRITATIONS - RED LINES ALONG WHERE THE DEVICE WAS LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681131 INDEX¿ BPM SMART BLOOD PRESSURE MONITOR SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN YA HORNG ELECTRONIC CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male