BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AROBELLA QOUSTIC SYSTEM

    MDR report key: 24698941 · Received March 26, 2026

    Report

    Report Number
    MW5185913
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 23, 2026
    Manufacturer
    AROBELLA MEDICAL, LLC.
    Product Code
    NRB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RESIDENT TESTED POSITIVE FOR GROUP A STREP IN HIS ABDOMINAL WOUND. HE WAS BEING SEEN BY OUR IN HOUSE WOUND PROVIDER WHO USE THE AROBELLA QOUSTIC SYSTEM (ULTRASOUND MIST THERAPY) ON THIS WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758231 AROBELLA QOUSTIC SYSTEM WOUND CLEANER, ULTRASOUND NRB AROBELLA MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other