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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVID TEST NASAL CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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COVID TEST NASAL CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Unspecified Respiratory Problem (4464); Swelling/ Edema (4577)
Event Date 01/08/2022
Event Type  Injury  
Event Description
Covid test jammed up nose-now swelling, inflammation and stuffiness. Was sick early november. Unknown hospital can't even tell. Fda safety report id# (b)(4).
 
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Brand NameCOVID TEST NASAL
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
MDR Report Key13257849
MDR Text Key283957563
Report NumberMW5106656
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 01/13/2022 Patient Sequence Number: 1
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