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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 Patient-Device Incompatibility (2682)
Patient Problem Pain (1994)
Event Date 12/21/2021
Event Type  Injury  
Event Description
Oti received medwatch report, mw5108226, via mail from the fda.Consumer voluntarily submitted the mdr for inteliswab covid-19 rapid test.Consumer stated within an hour after using inteliswab they started having pain throughout sinus, face, ears, and teeth.They went to a clinic who advised the pain/irritation could be allergy, viral, or bacterial.Consumer took benadryl and zyrtec.Consumer tests weekly and is still having issues today.Consumer also added they had a rhinoplasty surgery in the past.
 
Manufacturer Narrative
On 3/31/2022 additional information added to section b.5.Describe event or problem.At this time, no further information is expected by this consumer in order to continue an investigation.This complaint file will be closed internally.
 
Event Description
Oti received medwatch report, mw5108226, via mail from the fda.Consumer voluntarily submitted the mdr for inteliswab covid-19 rapid test.Consumer stated within an hour after using inteliswab they started having pain throughout sinus, face, ears, and teeth.They went to a clinic who advised the pain/irritation could be allergy, viral, or bacterial.Consumer took benadryl and zyrtec.Consumer tests weekly and is still having issues today.Consumer also added they had a rhinoplasty surgery in the past.On 3/31/2022 additional information added: the consumer's mdr report, mw5108226 did not identify a product malfunction.However, the consumer stated they were instructed by a fellow worker on the use of device and did not follow the inteliswab ifu insert.
 
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Brand Name
INTELISWAB COVID-19 RAPID TEST
Type of Device
INTELISWAB
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 Key13942132
MDR Text Key288170730
Report Number3004142665-2022-00020
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 Other
Type of Report Initial,Followup
Report Date 03/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
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 Received03/29/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/22/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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