MAUDE Adverse Event Report: COVID 19 TEST; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burning Sensation (2146)

Event Date 01/23/2022

Event Type  Injury  

Event Description

Hello, my name is (b)(6) i have had my covid19 vaccines and booster, but was recently exposed to a family member who had a fever and tested positive for covid.I masked, self-distanced for five days and scheduled an appointment with our after hours clinic for sunday morning.Upon arrival for my appointment, i was informed and i accepted that since i did not have symptoms, they could only perform the "send-off" test and i would have to wait several days for results.I have a very high pain threshold and had already experienced a "quick-test" last year, so i was prepared to have my "eyeballs touched" with the swab.However, i was not prepared for this test.Upon the nurse's gentle insertion of the cotton swab, i felt a painful, burning sensation in my nostril and my eyes started watering.It was not like alcohol or saline, more like a "chemical" burning sensation.This pain was even before she had the swab completed inserted.I told her it was burning, as she proceeded to insert into my other nostril, which also burned immediately! she completed her test and said the burning was normal and should subside in a few minutes, which it did.I told her i had not have an issue with the "quick test" i had last year and asked why with this test, it would burn like that before she even got it up in my nose, she said all tests are different and people react in different ways.I left the facility, knowing i would have to wait on the results, and went on to church.Thirty minutes after the test and during the first prayer at church, my nose started to run uncontrollably.(thank goodness for the mask until i could reach my tissues.) it did eventually stop, but i started thinking again about the "burning" test swab.After church, i contacted my pharmacist, to ask if they had any reported issues like mine and what is on the swab to which i would have reacted so violently? they had no reports of "burning" and that the swab should have been just a clean swab.I have also reached out to my physician, but have not yet heard back from them.I know you are busy, but this greatly concerns me.What could have been on that swab and how did it get there and will i possibly have issues later from whatever "chemical" was on the swab and entered into my nose? i appreciate your time and attention.Stay well and have a blessed day.Fda safety report id# (b)(4).

• Brand Name: COVID 19 TEST
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• MDR Report Key: 13366273
• MDR Text Key: 284622078
• Report Number: MW5107001
• Device Sequence Number: 1
• Product Code: QJR
• 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: 01/24/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2022
• Patient Sequence Number: 1
• Treatment: B12; CALCIUM W/VITD; CHOLESTEROL,; MEDS FOR BP, ; MULTI VITAMIN. ; THYROID,
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White