BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WOUND CLEANER, ULTRASOUND

    MDR report key: 22347883 · Received June 26, 2025

    Report

    Report Number
    MW5172049
    Event Type
    Injury
    Date Received
    June 26, 2025
    Date of Event
    April 26, 2025
    Report Date
    June 23, 2025
    Manufacturer
    AROBELLA MEDICAL, LLC
    Product Code
    NRB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    USE OF ULTRAMIST DEVICE FOR WOUND CARE. PATIENT TESTED POSITIVE FOR INVASIVE GROUP A STREP WITH NECROTIZING FASCIITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262394 WOUND CLEANER, ULTRASOUND ULTRAMIST NRB AROBELLA MEDICAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other| H| L| R