BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAMIST

    MDR report key: 25068853 · Received May 4, 2026

    Report

    Report Number
    MW5187550
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    January 12, 2026
    Report Date
    April 28, 2026
    Manufacturer
    SANUWAVE, INC.
    Product Code
    NRB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS INDIVIDUAL RECEIVED WOUND CARE AT HOME FROM A PHYSICIAN'S ASSISTANT WHO USED A WOUND MIST DEVICE CALLED ULTRAMIST. AFTER ROUTINE USE OF THIS DEVICE, THIS INDIVIDUAL HAD A WOUND CULTURE POSITIVE FOR ACINETOBACTER BAUMANNII WITH OXA 23 CARBAPENEMASE. THE WOUND CARE AGENCY WHO USED THE DEVICE HAS HAD SEVERAL OTHER PATIENTS WITH THIS SAME ORGANISM, INCLUDING PEOPLE WHO WERE TREATED WITH THE ULTRAMIST, SO I AM CONCERNED THAT THE DEVICE COULD BE A SOURCE OF CROSS-CONTAMINATION BETWEEN PATIENTS WHO ALSO RECEIVE THE ULTRAMIST, OR POSSIBLY THAT THE MIST IS CONTAMINATING THE PROVIDERS EQUIPMENT THAT THEN GOES INTO ANOTHER PERSON'S HOME. THE ULTRAMIST HAS A REUSABLE PIECE, THE "TREATMENT WAND TIP", ACCORDING TO THE IFU (HTTPS://USERMANUAL.WIKI/CELLERATION-ORPORATED/CP-80033-2321743.PDF), THAT GETS EXTREMELY CLOSE/POSSIBLY TOUCHES THE WOUND BED, SO I AM CONCERNED THAT TIP COULD BE A CAUSE OF CONTAMINATION OR, AGAIN, THAT THE MIST IS EITHER AEROSOLIZING OR JUST CAUSING SPLASH/SPRAY AND CONTAMINATED OTHER REUSABLE EQUIPMENT. THIS PERSON IS PART OF A 16-PERSON OUTBREAK IN OUR REGION, AND IS 1 OF 4 INDIVIDUALS WHO RECEIVED ULTRAMIST PRIOR TO DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29363 ULTRAMIST WOUND CLEANER, ULTRASOUND NRB SANUWAVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Hospitalization