MAUDE Adverse Event Report: ABBOTT BINAXNOW COVID-19; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number 195-100

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

Patient Problems Headache (1880); Burning Sensation (2146)

Event Date 11/08/2021

Event Type  Injury  

Event Description

At the outset of having to test on a consistent basis to enter a federal installation i used the nasal swab test and every time i tested the inside of both nostrils burned and i have consistent headaches.Now that i am having to test everyday beginning (b)(6) 2022 to enter the federal facility the burning of my nostrils continues and the headaches get progressively worse with each day.Binaxnow covid 19 tests that were administered starting on (b)(6) 2021 continuing through (b)(6) 2022.For the month of (b)(6) 2022.I have tested fifteen times and the burning of my nostrils continues and the headaches get progressively worse with each day.Fda safety report id # (b)(4).

• Brand Name: BINAXNOW COVID-19
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 13995281
• MDR Text Key: 288590680
• Report Number: MW5108716
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/31/2022
• 15 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/21/2022
• Device Model Number: 195-100
• Device Lot Number: 175620
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Race: White