BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELUXWRIST BLOOD PRESSURE MONITOR

    MDR report key: 21392049 · Received February 18, 2025

    Report

    Report Number
    MW5166183
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    February 10, 2025
    Report Date
    February 11, 2025
    Manufacturer
    FKA DISTRIBUTING CO., LLC./HOMEDICS USA, LLC.
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED A WALGREENS BLOOD PRESSURE MONITOR AFTER MY DOCTOR DIAGNOSED ME WITH HYPERTENSION. I HAVE BEEN USING IT FOR SEVERAL MONTHS AND ASSUMED IT WAS ACCURATE. ON 2 OCCASIONS WITH THE DELUXE WRIST BLOOD PRESSURE MONITOR I WAS GETTING SEVERAL LOW READINGS 90 OVER 50 ETC. I WENT TO THE (B)(6) YESTERDAY AND MY BLOOD PRESSURE WAS 130 OVER 70. I CAME HOME AND USED THE WALGREENS DEVICE AND IT WAS 100/50 15 MINUTES LATER. I BELIEVE IT IS DANGEROUS FOR PEOPLE TO BE USING THESE MONITORS AND NOT REALIZING THEY COULD HAVE SERIOUS HEART PROBLEMS. THIS IS THE SECOND MONITOR I HAVE BOUGHT AND THEY BOTH HAVE THE SAME ISSUES. REFERENCE REPORT #MW5166184.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 03/06/2025 FOR REPORT NUMBER MW5166183 TO UPDATE MANUFACTURER'S NAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982916 DELUXWRIST BLOOD PRESSURE MONITOR SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN FKA DISTRIBUTING CO., LLC./HOMEDICS USA, LLC. WGHBPW-210A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male LISINIPROL.