BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGARD

    MDR report key: 21841752 · Received April 15, 2025

    Report

    Report Number
    3004513970-2025-00003
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    March 18, 2025
    Report Date
    April 15, 2025
    Manufacturer
    RESOURCE OPTIMIZATION & INNOVATION, LLC
    Product Code
    DXQ
    PMA / PMN Number
    K921997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS NOT PROVIDED BY THE INITIAL REPORTER, SO THE UDI NUMBER ONLY CONTAINS THE PRIMARY DI NUMBER.

    Description of Event or Problem · 0

    CUSTOMER IS GETTING HIGH BLOOD PRESSURE READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2378722 REGARD DISPOSABLE NEO SOFT CUFF #1 3-6 CM DXQ RESOURCE OPTIMIZATION & INNOVATION, LLC BPNEO1-REG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown