inforMED
InjuryKMA

NAVAGE NASAL CARE

Received Jul 9, 2024 · Event occurred Nov 29, 2023

Report MW5157153 · MDR key 19713952

Device

Generic name

Irrigator, Powered Nasal

Manufacturer

Rhinosystems, Inc.

Model number

SDG-2

Patient

59 YR · Female

  • Nerve Damage
  • Tinnitus
  • Neck Pain
  • Partial Hearing Loss
  • Swelling/ Edema
  • Ear infection
  • Nerve Damage
  • Tinnitus
  • Neck Pain
  • Partial Hearing Loss
  • Swelling/ Edema
  • Ear infection

Narrative

Description of Event or Problem

11/4/2023 RECEIVED MY NEW NAVAGE NOSE IRRIGATION MACHINE USED NAVAGE NOSE IRRIGATION MACHINE FOR 3 TIMES OVER THE NEXT WEEK, USING PROPER INSTRUCTIONS; (B)(6) 2023 ¿ MY RIGHT EAR HAD SWELLED UP LIKE 3 TIMES THE SIZE AND DOWN THE SIDE OF MY NECK WAS IN PAIN. MY EAR WAS RINGING. THE DOCTOR ASKED IF I HAD BEEN ON VACATION OR SWIMMING SOMEWHERE, BUT I SAID NO AND SAID I HAD DEVELOPED SWIMMER'S EAR WITH WATER TRAPPED BEHIND MY EAR DRUM. DR. PRESCRIBED AMOXICILLIN FOR 10 DAYS, NEOMYCIN-POLYMYXIN EAR DROPS FOR 4 DAYS AND MUPIROCIN OINTMENT FOR 7 DAYS. ON (B)(6) 2023 ¿ EAR STILL NOT BETTER. DR. PRESCRIBED AZITHROMYCIN (ZPAC) FOR SEVERAL DAYS (B)(6) 2024 FOLLOW UP WITH DR. STILL NOT BETTER AND RINGING IN MY EAR. DID BLOOD WORK AND REFERRED ME TO AN ENT DR. (B)(6) 2024, ENT DR. DID HEARING TEST AND PARTIAL LOSS OF HEARING IN MY RIGHT EAR AND STILL RINGING IN MY EAR. PRESCRIBED PREDNISONE 10MG (42 PILLS) TO BE TAKEN OVER THE NEXT 10 DAYS. ON (B)(6) 2024 FOLLOW UP WITH ENT DR. NOW ORDERED MRI. ON (B)(6) 2024 COMPLETED MRI (B)(6) 2024 ¿ FOLLOW UP WITH ENT DR. AND SAID PERMANENT DAMAGE TO THE (B)(6) 2024 ¿ IN DISBELIEF I THOUGHT WELL MAYBE IT WILL HEAL IN TIME. I STILL HAVE CONSTANT RINGING IN MY EAR.