inforMED
InjuryNRB

ULTRAMIST

Received May 4, 2026 · Event occurred Jan 12, 2026

Report MW5187550 · MDR key 25068853

Device

Generic name

Wound Cleaner, Ultrasound

Manufacturer

Sanuwave, Inc.

Patient

52 YR · Male

  • Bacterial Infection

Narrative

Description of Event or Problem

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.