FDA Adverse Event Injury Summary report: N

NASOGEL

MDR report key: 21221114 · Received January 22, 2025

Report

Report Number
MW5165163
Event Type
Injury
Date Received
January 22, 2025
Date of Event
December 15, 2024
Report Date
January 20, 2025
Manufacturer
NEILMED PHARMACEUTICALS, INC.
Product Code
KCJ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NE, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

NOSEBLEEDS WITH CLOTS, NAUSEA, DIARRHEA, STOMACH CRAMPS, DIZZINESS. I STOPPED USING IT AND THE SIDE EFFECTS SUBSIDED WITHIN A WEEK, EXCEPT MY NOSE STILL BLEEDS, BUT NOT AS OFTEN OR AS MUCH. I KEPT THE BOTTLES FOR TESTING IN A ZIPLOCK. AMAZON NOTIFIED ME OF THE RECALL. DRY SINUSES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
607034 NASOGEL APPLICATOR, ENT KCJ NEILMED PHARMACEUTICALS, INC.

Patients

Seq Age Sex Outcome Treatment
1 63 YR Female Other ALLERGY MED| BLOOD THINNER| BP MED| CHOLESTEROL MEDICATION| CPAP| KEYTRUDA | LENVIMA| MINERALS AND SUPPLEMENTS MY WHOLE LIFE.| NUMEROUS - HAVE TAKEN VITAMINS