MAUDE Adverse Event Report: RHINOSYSTEMS, INC. NAVAGE; IRRIGATOR, POWERED NASAL

Device Problem Failure to Prime (1492)

Patient Problems Pain (1994); Fluid Discharge (2686); Swelling/ Edema (4577)

Event Date 12/29/2022

Event Type  Injury  

Event Description

I went to use navage nasal machine.Machine failed to prime and air was sent into sinus passages causing extreme pain swelling and discharge.

• Brand Name: NAVAGE
• Type of Device: IRRIGATOR, POWERED NASAL
• Manufacturer (Section D): RHINOSYSTEMS, INC.
• MDR Report Key: 16132154
• MDR Text Key: 307080263
• Report Number: MW5114241
• Device Sequence Number: 1
• Product Code: KMA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White