BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGARD

    MDR report key: 23706452 · Received December 3, 2025

    Report

    Report Number
    3004513970-2025-00012
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 4, 2025
    Report Date
    December 3, 2025
    Manufacturer
    RESOURCE OPTIMIZATION & INNOVATION, LLC
    Product Code
    DXQ
    UDI-DI
    10326053121576
    PMA / PMN Number
    K921997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THE BLOOD PRESSURE CUFF OVERINFLATED, CAUSED PAIN, BRUISING, AND DISPLAYED AN INCORRECT READING WHEN ATTEMPTING TO TAKE A BLOOD PRESSURE. THIS CAUSED THE BLOOD PRESSURE TO BE RETAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2854245 REGARD COMFORT CHECK DISPOSABLE BLOOD PRESSURE CUFF LARGE ADULT LONG (33-41 CM) DXQ RESOURCE OPTIMIZATION & INNOVATION, LLC DBPLGADLTL-REG UNKNOWN 10326053121576

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown