BEUDAMED
    FDA Adverse Event Other Summary report: N

    AROBELLA ULTRA

    MDR report key: 24702365 · Received March 26, 2026

    Report

    Report Number
    MW5185973
    Event Type
    Other
    Date Received
    March 26, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 23, 2026
    Manufacturer
    AROBELLA MEDICAL, LLC
    Product Code
    NRB
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE MIST MACHINE WAS USED WITHOUT CHANGING THE BAG OR THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756373 AROBELLA ULTRA WOUND CLEANER, ULTRASOUND NRB AROBELLA MEDICAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other