MAUDE Adverse Event Report: NEILMED PHARMACEUTICALS, INC. NEILMED NASOGEL DRY NOSES DRIP FREE SPRAY; NASAL SPRAY, ENT DELIVERY

Lot Number	NGS762
Health Effect - Clinical Codes	Headache (1880); Nausea (1970); Burning Sensation (2146); Epistaxis (4458)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Began using neilmed nasogel dry noses drip free spray on (b)(6) 2024.The nose spray caused severe congestion, severe throat burning, severe burning in nose, burning in both eyes, nausea, sinus pressure, nose bleeds, and a headache.The symptoms worsened as i continued to use the product and did not begin to ease until i discontinued using the product after realizing it may have been causing the problem.I have since discovered that the spray i was using was part of a recall due to microbial contamination.I am still having throat burning and congestion.Dates of use: (b)(6) 2024 - (b)(6) 2025.Reason for use: dry nose.

• Brand Name: NEILMED NASOGEL DRY NOSES DRIP FREE SPRAY
• Common Device Name: NASAL SPRAY, ENT DELIVERY
• Manufacturer (Section D): NEILMED PHARMACEUTICALS, INC.
• MDR Report Key: 21141818
• Report Number: MW5164588
• Device Sequence Number: 9176230
• Product Code: KCO
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: NGS762
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White