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U.S. Department of Health and Human Services

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

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ORASURE TECHNOLOGIES, INC. INTELISWAB COVID-19 RAPID TEST Back to Search Results
Catalog Number 1001-0622
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Hemorrhage/Bleeding (1888); Pain (1994)
Event Date 05/14/2022
Event Type  Injury  
Manufacturer Narrative
Date of medwatch report mw5109755 was noted to be (b)(4) 2022. Consumer provided the lot number of the inteliswab test kit (21036-01x) and expiration date is 03/22/2022. Consumer did not provide date they used the inteliswab tests.
 
Event Description
Oti received medwatch report mw5109755, via email from the fda. Consumer voluntarily submitted the mdr for inteliswab. Consumer stated after using inteliswab they started having sinus, headache, bloody nose and ear pain. Consumer stated the symptoms would last the remainder of test day, the following day and on the third day only a little remainder of blood remained in the nose. Consumer stated they used the test exactly as described in the instructions except the consumer was only required to use one swab in the kit per week as long as they tested negative. Consumer took a total of 5 tests. As the covid levels went down in the community, the consumer stopped testing.
 
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Brand NameINTELISWAB COVID-19 RAPID TEST
Type of DeviceINTELISWAB
Manufacturer (Section D)
ORASURE TECHNOLOGIES, INC.
220 east first street
bethlehem PA 18015
Manufacturer (Section G)
ORASURE TECHNOLOGIES, INC.
220 east first street
bethlehem PA 18015
Manufacturer Contact
jennifer krause
220 east first street
bethlehem, PA 18015
6108821820
MDR Report Key14465243
MDR Text Key292392973
Report Number3004142665-2022-00023
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA210378
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Expiration Date03/22/2022
Device Catalogue Number1001-0622
Device Lot Number21036-01X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/20/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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