BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELCH ALLYN, INC.

    MDR report key: 19380526 · Received May 23, 2024

    Report

    Report Number
    19380526
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    January 22, 2024
    Report Date
    January 31, 2024
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    DXQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS DISCONNECTED FROM THE WALL BLOOD PRESSURE MONITOR PATIENT STATED HER LEFT UPPER ARM WAS ITCHING. TWO HIVES WERE IDENTIFIED ON HER LEFT INNER ARM, PINK AND RAISED, SMALLER THAN DIMES. PATIENT WAS NOT IN DISTRESS AND DIDN'T SCRATCH THEM BUT SHE WAS AWARE OF THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609299 WELCH ALLYN, INC. BLOOD PRESSURE CUFF DXQ WELCH ALLYN, INC. 23328

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Unknown