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

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.

• Brand Name: QUIDEL SOFIA NASAL SWAB
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORPORATION
• MDR Report Key: 12820415
• MDR Text Key: 280878925
• Report Number: MW5105340
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• 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
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White