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

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Tinnitus (2103)

Event Date 04/05/2023

Event Type  Injury  

Event Description

Extreme ear pain after product usage.Ringing in ear persists.

• Brand Name: NAVAGE
• Type of Device: IRRIGATOR, POWERED NASAL
• Manufacturer (Section D): RHINOSYSTEMS, INC.
• MDR Report Key: 16707323
• MDR Text Key: 313064399
• Report Number: MW5116489
• 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: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALGAE OIL ; ECHINACEA ; FINASTERIDE; MULTIVITAMIN VIT B12 ; ZINC
• Patient Outcome(s): Disability; Other
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White