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U.S. Department of Health and Human Services

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

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ORASURE TECHNOLOGIES, INC. INTELISWAB COVID-19 RAPID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
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).
 
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Brand NameINTELISWAB COVID-19 RAPID TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
ORASURE TECHNOLOGIES, INC.
MDR Report Key14429966
MDR Text Key292033920
Report NumberMW5109755
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received05/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Expiration Date05/31/2022
Device Model NumberCOVID-19 RAPID TEST
Device Lot Number21036-01X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 05/17/2022 Patient Sequence Number: 1
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