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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Skin Inflammation/ Irritation (4545)

Event Date 12/21/2021

Event Type  Injury  

Event Description

Sinus, head and ear pain; inteliswap covid 19 rapid test home test nasal swab came with no data sheet.Instructed by fellow worker on use.Immediate sinus clearing by testimony of several individuals ( like vicks up your nose) within an hour pain started throughout sinus, face, ears and teeth.Went to clinic noticed irritation stated could be allergy, viral or bacterial.Next week took benadryl same affect, following week tried zyrtec same affects just getting worse because there is no healing time in between.Had to endure 5 tests for work until unable to withstand the pain.Had rhinoplasty surgery in the past.Please advise.Test weekly from (b)(6) 2021 thru (b)(6) 2022.Still having issues today (b)(6) 2022.Fda safety report id # (b)(4).

• Brand Name: INTELISWAB RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ORASURE TECHNOLOGIES, INC.
• MDR Report Key: 13808377
• MDR Text Key: 287575217
• Report Number: MW5108226
• Device Sequence Number: 3
• 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: 03/15/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: VITAMIN C
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic