FDA Adverse Event Injury Summary report: N

NAVAGE

MDR report key: 18552857 · Received January 19, 2024

Report

Report Number
MW5150602
Event Type
Injury
Date Received
January 19, 2024
Date of Event
January 3, 2022
Report Date
January 18, 2024
Manufacturer
RHINOSYSTEMS, INC.
Product Code
KMA
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MD, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
406000 NAVAGE IRRIGATOR, POWERED NASAL KMA RHINOSYSTEMS, INC. B01787L6QY

Patients

Seq Age Sex Outcome Treatment
1 57 YR Female Disability| O OREGANO OIL.| SALINE NASAL SPRAY.| VITAMIN C.| ZINC.