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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Pain (1994); Inadequate Pain Relief (2388); Unspecified Ear or Labyrinth Problem (4474)

Event Date 12/02/2020

Event Type  Injury  

Event Description

I used navage nose irrigation machine one year and four months ago, twice, each time less than a minute on (b)(6) 2020.When i used it i felt pain in my middle ears.Because of this i stopped using it and returned it to the vendor.But the pain didn't go away.After one year and four months still i have constant pain, pressure, and congestion in both of my middle ears.It is very annoying.In addition, after i used navage i got infection in both of my middle ears and i took antibiotics for one month.I have visited several ent specialists.So far they haven't been able to help.I have also had several tests including ct scan of my middle ears, audiogram, and tympanometry.In total, i visited seven doctors: four ent specialists and three urgent care physicians.If i knew water goes into my middle ears, i would not have bought navage.Navage presentation doesn't show that water goes into our middle ears.Please see their website at www.Navage.Com.It shows that water goes into one nostril and comes back from the other nostril.But in reality water first goes from our eustachian tube into our middle ears.Then the overflow water comes back from the other nostril.At the time that i bought navage i didn't know that there is a tube that connects our nostril to our middle ear.Also, navage gives us the option to use either filtered water or distilled water for the irrigation.If they asked us to use only distilled water, i may not have gotten middle ear infection.It is insane that i used navage just for a few seconds and it has caused me constant pain, pressure, congestion, and discomfort in both of my middle ears for one year and for months.I am worried that this problem will stay with me for the rest of my life.Fda safety report id# (b)(4).

• Brand Name: NAVAGE NASAL CARE
• Type of Device: IRRIGATOR, POWERED NASAL
• Manufacturer (Section D): RHINOSYSTEMS, INC.
• MDR Report Key: 14021607
• MDR Text Key: 288808912
• Report Number: MW5108787
• Device Sequence Number: 2
• 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: 04/02/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Sex: Male