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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUIDEL CORPORATION QUIDEL SOFIA NASAL SWAB CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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QUIDEL CORPORATION QUIDEL SOFIA NASAL SWAB CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Asthma (1726)
Event Date 11/08/2021
Event Type  Injury  
Event Description
Have had 4 quidel sofia nasal swab tests and each time it triggers an asthma attack. The quidel sofia nasal swab for covid 19 quick test was performed at (b)(6). Each time i have had the swab, it has exacerbated my asthma condition.
 
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Brand NameQUIDEL SOFIA NASAL SWAB
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
QUIDEL CORPORATION
MDR Report Key12820415
MDR Text Key280878925
Report NumberMW5105340
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 11/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 11/15/2021 Patient Sequence Number: 1
Treatment
ASPIRIN; BALANCE OF NATURE FRUITS/VEGETABLES; CALTRATE; METHOTREXATE; PANTOPRAZOLE; PREDNISONE; PRO AIR; RHEUMATE ; SINGULAIR; SYNTHROID; TART CHERRY EXTRACT ; TYLENOL ARTHRITIS ; VITAMIN C ; VITAMIN D3; ZINC
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