MAUDE Adverse Event Report: SALVACION INTERNATIONAL, LLC. / SALVACION USA, INC. COVIXYL NASAL SPRAY HELPS BLOCK AIRBORNE VIRUSES; NASAL SPRAY, ENT DELIVERY

Lot Number OTL230106

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 03/11/2023

Event Type  Injury  

Event Description

I tried this product and it burned my nostril and who knows what else, and i had a very serious nasal pain.They are selling this product on amazon and walmart, blasting on facebook with claims this product can be sprayed in the nose and protect people from covid.There seems to be a ton of shill reviews.Https://www.Amazon.Com/covixyl-protective-airborne -fast- acting-protection/dp/b0b65zhnhy/ref=cm_cr_sr p_d_product_top?ie=utf8 i screenshot a question where someone asked if they are fda approved.After all this stuff is ingested through the nose, so this is up for debate.Here is their answer" "covixyl paula carmichael i'll respond in a few comments.First re: the fda.Covixyl occupies a weird space in the regulatory framework.We are legal to sell in the united states and in the uk (under a class i medical device ukca mark).Because covixyl is not a drug, there is not an fda 'approval.' due to the intended use, we fall into a category alongside gloves and masks.We are a topical nasal spray intended to block viruses from gaining access to your nasal cells.All of our ingredients are designated by the fda as gras (generally recognized as safe) and the nih performed a battery of tests last year (a cascade assay) designed to demonstrate there is no sensitivity to the product (even when sprayed in the eyes or mouth) and that there are no side effects or physiological metabolization of the product.After several hours, the ingredients break down into simple amino acids.Topical nasal sprays such as ours are gaining interest in the public, which we expect to translate to the fda creating a new category for products like ours that will allow for a simple approval in the future.We, along with a few other companies, are creating a new class of product that doesn't fit well within the current framework.The eu is evaluating us for a class iia medical device designation and an explicit covid/flu prevention claim, but that's still 6 months or so away.".

• Brand Name: COVIXYL NASAL SPRAY HELPS BLOCK AIRBORNE VIRUSES
• Type of Device: NASAL SPRAY, ENT DELIVERY
• Manufacturer (Section D): SALVACION INTERNATIONAL, LLC. / SALVACION USA, INC.
• MDR Report Key: 16583251
• MDR Text Key: 311749156
• Report Number: MW5115856
• Device Sequence Number: 1
• Product Code: KCO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/15/2023

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
• Device Expiration Date: 01/20/2023
• Device Lot Number: OTL230106
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2023
• Patient Sequence Number: 1
• Treatment: BIOTIN 10000MCG ; COLLAGEN PILLS 1000MG ; FOLIC ACID ; GARLIC OIL CAPS; HYALURONIC ACID - HAIR SKIN AND NAILS VITAMINS AND DHT BLOCKER WITH VITAMIN E ; KERATIN ; MULTIVITAMINS; NATUREALM SACRED 7 MUSHROOM EXTRACT CAPSULES ; NIACIN; PUMPKIN SEED MSM ; SAW PALMETTO 2500MG
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White