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