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

Model Number B01787L6QY

Patient Problems Tooth Fracture (2428); Sleep Dysfunction (2517); Neuralgia (4413)

Event Date 01/03/2022

Event Type  Injury  

Event Description

In (b)(6) of 2021, i purchased a navage sinus irrigation system from amazon.Com.It worked great at first, but after a few uses in early (b)(6), i felt a severe sharp pain run through my right sinus cavity, down past my ear, into my jaw, under my gums and bottom tooth.The pain became worse each day.I have not been able to chew on my right side ever since.I also suffer from what i assume is nerve pain on the side of my face, which has disrupted my sleep.Most days i am in tears and have to use ice packs.My dentist determined the tooth at the point of injury was badly cracked.I had to have the tooth pulled in that area affected by the injury, and still have trouble chewing.I immediately returned the product to amazon and left a review to warn others.I called navage.I spoke with one of the owners to see if they would offer some sort of compensation for medical bills, but instead she laughed at my situation, and was quite cruel.I then asked if they could add a warning label advising customers with nasal polyps not to use the product.Again, i was met with hostility.They said that their staff ear, nose, and throat would be in touch with me, which eventually happened.But he refused to admit the navage was at fault and said that i must have had a cracked tooth all along.It is important to note that i never had any dental issues my entire life prior to this, and the cracked tooth was at the exact location above the gum where the shooting pain and pressure came to a head when using navage.This is a dangerous product in my experience, and i am not the only one.And the way they treated me was horrible.I highly recommend not using navage.I have been seeing an acupuncturist for easing the nerve pain, and have had to have dental work done, with more pending.

• Brand Name: NAVAGE
• Type of Device: IRRIGATOR, POWERED NASAL
• Manufacturer (Section D): RHINOSYSTEMS, INC.
• MDR Report Key: 18552857
• MDR Text Key: 333521367
• Report Number: MW5150602
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: B01787L6QY
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: OREGANO OIL.; SALINE NASAL SPRAY.; VITAMIN C.; ZINC.
• Patient Outcome(s): Disability; Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White