MAUDE Adverse Event Report: ORASURE TECHNOLOGIES, INC. INTELISWAB COVID-19 RAPID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number COVID-19 RAPID TEST

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

Patient Problems Headache (1880); Hemorrhage/Bleeding (1888); Pain (1994)

Event Type  Injury  

Event Description

I have been serial testing for work, using inteliswab covid 19 rapid test home test nasal swab without any covid 19 symptoms.I have had sinus, headache, blood in nose and ear pain after the test.The symptoms would last for the remainder of the day of testing and the next day, the third day only a little remaining blood in the nose.I use it exactly as described in the instructions except we were only required to use one swab in the kit per week when testing negative.I took a total of 5 tests.As the community covid levels went to low we stopped testing my symptoms cleared up.Fda safety report id # (b)(4).

• Brand Name: INTELISWAB COVID-19 RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ORASURE TECHNOLOGIES, INC.
• MDR Report Key: 14429966
• MDR Text Key: 292033920
• Report Number: MW5109755
• 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: Patient
• Type of Report: Initial
• Report Date: 05/14/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/31/2022
• Device Model Number: COVID-19 RAPID TEST
• Device Lot Number: 21036-01X
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White