BEUDAMED
    FDA Adverse Event Summary report: N

    BLOOD PRESSURE MONITOR

    MDR report key: 16272029 · Received January 30, 2023

    Report

    Report Number
    MW5114567
    Date Received
    January 30, 2023
    Report Date
    February 9, 2023
    Manufacturer
    HOMEDICS GROUP CANADA
    Product Code
    DXN
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS MACHINE GIVES ME LOW READINGS AND THEREFORE, I HAVE NOT TAKEN MY BLOOD PRESSURE MEDICATION IN WEEKS, AND I HAVE BEEN HAVING HEADACHES AND PRESSURE IN MY EYESIGHT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 02/09/2023 FOR MW5114567. MY BLOOD PRESSURE HAS BEEN REGISTERING VERY LOW NUMBERS, AND THEREFORE CAUSING ME TO NOT TAKE MY BLOOD PRESSURE MEDICATION IN FEAR OF MY HEART STOPPING. IF I DON'T HEAR BACK FROM THIS COMPANY I WILL BE SEEKING A LAWYER'S ADVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401961 BLOOD PRESSURE MONITOR SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN HOMEDICS GROUP CANADA WGNBPA-950

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown