FDA Adverse Event
Injury
Summary report: N
ULTRAMIST
MDR report key: 25046927
·
Received April 30, 2026
Report
- Report Number
- MW5187500
- Event Type
- Injury
- Date Received
- April 30, 2026
- Date of Event
- December 23, 2025
- Report Date
- April 27, 2026
- Manufacturer
- SANUWAVE, INC.
- Product Code
- NRB
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 428839 | ULTRAMIST | WOUND CLEANER, ULTRASOUND | NRB | SANUWAVE, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |