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U.S. Department of Health and Human Services

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

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QUIDEL CORP. QUIDEL QUICKVUE ANTIGEN TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
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).
 
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Brand NameQUIDEL QUICKVUE ANTIGEN TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
QUIDEL CORP.
MDR Report Key12933596
MDR Text Key281842683
Report NumberMW5105774
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 12/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
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: 12/03/2021 Patient Sequence Number: 1
Treatment
VITAMIN C; VITAMIN D; ZINC
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