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 |