MAUDE Adverse Event Report: NEUROCARE PRO LLC BRAIN CAP 280; LAMP, INFRARED, THERAPEUTIC HEATING

Catalog Number NPBC280

Device Problem Device Emits Odor (1425)

Patient Problems Headache (1880); Inflammation (1932); Nausea (1970); Red Eye(s) (2038); Dizziness (2194); Sore Throat (2396); Swollen Lymph Nodes/Glands (4432); Unspecified Respiratory Problem (4464); Unspecified Eye / Vision Problem (4471)

Event Date 06/09/2022

Event Type  Injury  

Event Description

I had ordered two medical devices from the company neurocare pro.The items arrived in a cardboard box and the moment i opened that box, i was overwhelmed by the very strong smell of chemicals.I do not know why the products smell like this but it must be something in the manufacture of the product - perhaps in the fabric.The offensive chemical odor made my throat hurt.I was really looking forward to using the products for my health conditions.One item is a brain cap even setting the items in the next room, i could still smell them in their plastic bags.The throat condition got worse with my nasal passages feeling irritated.By the evening with this item in the house, my throat felt like it was closing up and i was feeling light-headed.My eyes were unusually red and inflamed.I hadn't noticed it at first with all of the other adverse symptoms but when i looked in the bathroom mirror, both eyes were red.The lymph nodes on my neck started to swell.My daughter reported a headache and that the smell was making her nauseous.She complained that her eyes were tearing.I had an air filter running all night and kept the windows open in the house to allow the items to air out some more.By this morning, the smell is still as strong as ever on the products.It smells like a paint thinner or something that could be very toxic.It's a very unnatural, chemical, potent and acrid smell.I woke up with my lymph nodes still swollen and a scratchy throat that would not have been experienced otherwise.I have been fine with no symptoms prior to exposure to the products.I have moved the products to the other side of the house and my daughter and i can still smell them.My throat remains scratchy and my daughter says the smell is making her want to throw up.I cannot just leave these items outside to air out because there are a lot of animals around and theft has been on the rise.I really would like to use these products and was glad to have received them but with this strong chemical smell that simply is burning and offensive, causing respiratory system changes, lightheadedness, eye irritation and swollen lymph nodes in me and then headache, eye irritation plus tearing of the eyes and nausea in my daughter, this cannot possibly be innocuous or nothing at all.The company claims that nothing is used on the product because it is a medical device and not even glue is used in the products' assembly.They also claim that i am the first person to ever have reported a complaint about the smell of the product.I am chemically sensitive to cigarette smoke and some perfumes and fragrances but these products are over-the-top noxious in their off-gassing or whatever is going on.It's like sticking your face in a can of varnish (paint thinner) and being forced to breathe it constantly even if it is in the most distant room in the house.The company states on its website under the section that says "our guarantee" that they are "fda cleared." i'd just like to know what chemical or chemicals are used on this product that have also met the fda's alleged approval.The products are sealed up in their original bags plus two large plastic bags over them to try to lock in the burning and irritating smell.My throat has been hurting the whole time i have been typing this and i have residual lightheadedness and my daughter says her eyes are still tearing and she feels nauseous.Fda safety report id # (b)(4).

• Brand Name: BRAIN CAP 280
• Type of Device: LAMP, INFRARED, THERAPEUTIC HEATING
• Manufacturer (Section D): NEUROCARE PRO LLC
• MDR Report Key: 14685453
• MDR Text Key: 293938640
• Report Number: MW5110299
• Device Sequence Number: 1
• Product Code: ILY
• 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: 06/10/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: NPBC280
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ANTI-INFLAMMATORY; THYROID REPLACEMENT
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic