MAUDE Adverse Event Report: NEILMED PHARMACEUTICALS, INC. NASO-GEL TUBE; APPLICATOR, ENT

Health Effect - Clinical Codes	Diarrhea (1811); Fall (1848); Head Injury (1879); Hemorrhage/Blood Loss/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Vomiting (2144); Chills (2191); Dizziness (2194); Loss of consciousness (2418)
Date of Event	10/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Reporter called to report that after using nasogel, she experienced severe reactions on two separate occasions: one, (b)(6) 2023, she took it in the evening and had chills and shivering, nausea and vomiting and was ill throughout the night and had to cancel her patient load for the following day.Two, (b)(6) 2023, she took nasogel at noon and by the evening had chills, dizziness, nausea and vomiting, diarrhea, loss of consciousness/falling and hitting her head with bleeding.Her husband was able to help her on this second incident.Reporter states that the nasogel is unsanitary, has mold and toxins in its ingredients, lacks rigorous testing by the manufacturer and quality control problems.Reporter states that the fda has issued warning letters about this product (may 26, 2023), https://www.Fda.Gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/neilmed-pharmaceuticals-inc-650263-05262023 where, the product continues to be a hazard to the public.

• Brand Name: NASO-GEL TUBE
• Common Device Name: APPLICATOR, ENT
• Manufacturer (Section D): NEILMED PHARMACEUTICALS, INC.
• MDR Report Key: 17886338
• Report Number: MW5146654
• Device Sequence Number: 14660631
• Product Code: KCJ
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female