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

Model Number VIPRB-00422

Event Date 11/15/2023

Event Type  Injury  

Event Description

Ordered the navage nasal care starter bundle nose cleaner from walmart on (b)(6) had it delivered to (b)(6), where i work; along with 1 gallon of pure life distilled water.Used it twice that day and everything was okay.It opened up my nasal passages and cleared the congestion.On (b)(6) i used it again.This time it felt weird.My ears popped and felt tight which made me put the machine into the cabinet and i have not used it since.However, ever since this time, i've felt pressure in my ears and just felt weird.I've since been to access urgent care 3 times, been diagnosed with a double ear infection and prescribed two sets of 10 day antibiotics.Yesterday, (b)(6) 2023 i went to an appointment with an ent(ear, nose, throat doctor) and was told i have negative ear pressure my ear drums are sucked inward.I fully believe the suction from the navage caused this and i may now need tubes in my ears to release the suction and allow my ear drums to return back to a normal state of pressure! navage does not disclose, nor show, water even entering into your ears.It simply shows it going through one nostril and out the other! this has been a costly, uncomfortable and awful experience.

• Brand Name: NAVAGE NASAL IRRIGATION SYSTEM
• Type of Device: IRRIGATOR, POWERED NASAL
• Manufacturer (Section D): RHINOSYSTEMS, INC.
• MDR Report Key: 18302858
• MDR Text Key: 330273182
• Report Number: MW5149082
• 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: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: VIPRB-00422
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: "TWO SETS OF 10 DAY ANTIBIOTICS".; LEVOTHYROXINE 200 MCG.; PURE LIFE DISTILLED WATER.
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White