MAUDE Adverse Event Report: QUIDEL CORP. QUIDEL QUICKVUE ANTIGEN TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problems Improper or Incorrect Procedure or Method (2017); Manufacturing, Packaging or Shipping Problem (2975); Patient Device Interaction Problem (4001)

Patient Problems Headache (1880); Burning Sensation (2146); Sore Throat (2396)

Event Date 11/30/2021

Event Type  Injury  

Event Description

I submitted to an antigen test, under duress, through my employer (b)(6).The setting was less than sanitary, the nurse never sanitized between testing subjects.The procedure was not uncomfortable but after the test, for hours, i experienced great burning in both nostrils, developed throat irritation and slight headache.Later in the evening, i blew my still sore nose and found pink on the tissue.Might i be having an allergic reaction to the sterilization used in the manufacturing of the swab? please advise; scheduled to test again on (b)(6) 2021 ".Worried!" fda safety report id# (b)(4).

• Brand Name: QUIDEL QUICKVUE ANTIGEN TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 12933596
• MDR Text Key: 281842683
• Report Number: MW5105774
• 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: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2021
• Patient Sequence Number: 1
• Treatment: VITAMIN C; VITAMIN D; ZINC
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Race: White