FDA Adverse Event Injury Summary report: N

INTELISWAB COVID-19 RAPID TEST

MDR report key: 14429966 · Received May 17, 2022

Report

Report Number: MW5109755
Event Type: Injury
Date Received: May 17, 2022
Report Date: May 14, 2022
Manufacturer: ORASURE TECHNOLOGIES, INC.
Product Code: QKP
Adverse Event: Yes
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: PA, US
Reporter Occupation: PATIENT
Health Professional: *

Narratives

Description of Event or Problem · 0

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).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot
1892470	INTELISWAB COVID-19 RAPID TEST	CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM	QKP	ORASURE TECHNOLOGIES, INC.	COVID-19 RAPID TEST	21036-01X
1892471	INTELISWAB COVID-19 RAPID TEST	CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM	QKP	ORASURE TECHNOLOGIES, INC.	COVID-19 RAPID TEST	21036-01X
1892472	INTELISWAB COVID-19 RAPID TEST	CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM	QKP	ORASURE TECHNOLOGIES, INC.	COVID-19 RAPID TEST	21036-01X
1892473	INTELISWAB COVID-19 RAPID TEST	CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM	QKP	ORASURE TECHNOLOGIES, INC.	COVID-19 RAPID TEST	21036-01X
1892474	INTELISWAB COVID-19 RAPID TEST	CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM	QKP	ORASURE TECHNOLOGIES, INC.	COVID-19 RAPID TEST	21036-01X

Patients

Seq	Age	Sex	Outcome	Treatment
1		Male	Other