MAUDE Adverse Event Report: CURATIVE, INC. CURATIVE ANTIGEN 1 HOUR TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Fatigue (1849); Headache (1880); Pain (1994)

Event Date 02/23/2022

Event Type  Injury  

Event Description

I had to take a 1 hour antigen test to go to a concert.I have never had a test before nor have i ever had covid19.As i drove to the test site about 30 minutes i realized my health was perfect, i felt great, was excited to go to the concert, i had absolutely zero issues.Breathing great and felt great.As soon as i was swabbed with by the employee and their test kits my right nose was slight stabbed too deep as i jumped up a bit ('it kinda' poked me once as he swirled/not just swirled like the left nostril).Immediately my right nostril started running clear water (for lack of better description) out.And wouldn't stop and while driving home the left nostril started running.Then i became excessively tired and took a hour and half nap.Completely out of character.I am not a napper.I woke up feeling groggy but eventually felt fine.And my nose was still running.Then i went to said concert (the reason for the test) and felt fine and my nose eventually after hours stopped running the entire time! i went to bed and woke up with a migraine.I have had only 2 others in my (b)(6) years of living.I drank coffee hoping it would help only to throw it up.Which has never happened.I believe the migraine made me feel sick to my stomach.I had to take 2 extra strength tylenol twice that next day.Which i consider doping up.I don't take pain killers nor any medication at all.So for me to take 2 500 milligrams twice in a day is me in severe pain.Which i have a very high threshold to pain.I do extreme sports and still skateboard to this day.Nonetheless it took 2 and a half days to 3 days to start to feel normal again.I guess i have it easy my cousin went to the on-site testing at (b)(6) center and she has a complete sinus infection and she was 100% perfect before test herself.I am extremely healthy and was very surprised to have this sudden onset acute sinus dripping and exhaustion to the point where i had to sleep and then to have extreme migraines i was shocked to know that what i had put in my nose to take a test literally was toxic to me.Third migraine ever.The other two were severe allergic reactions like me to this test.But the 1st migraine ever was from silver sugar sparkles on a wedding cupcake.And the 2nd was from clear sparkles on a different wedding cupcake.It was always the next morning waking up with severe head and sinus pain.This test was not the same allergic reaction as the sparkles on the cupcakes in so far as i did not have the face pain/sinus pain with the testing just my head.First the front cerebral then the sides simultaneously! like clamps above my ears to the top of my head.I also had an acute onset of a runny nose clear coming out like a 'sive.' i didn't have a runny nose with the cupcakes just the next morning waking up in severe pain with both.I am very sensitive to my health.Have perfect blood pressure and low body fat.Good cardiovascular conditioning.So this was very upsetting to have this side effect.I will never subject myself to that again.Unless to see a dying relative it was required as this was awful.Fda safety report id# (b)(4).

• Brand Name: CURATIVE ANTIGEN 1 HOUR TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): CURATIVE, INC.
• MDR Report Key: 13710618
• MDR Text Key: 286997450
• Report Number: MW5107946
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2022

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 Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White