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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT BINAXNOW COVID-19 AG CARD CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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ABBOTT BINAXNOW COVID-19 AG CARD CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Viral Infection (2248); Unspecified Respiratory Problem (4464); Unspecified Ear or Labyrinth Problem (4474)
Event Date 02/15/2022
Event Type  Injury  
Event Description
Nasal/auditory/sinus effect. I submitted to a nasal swab test as mandated for a select group of employees. I was not ill and showed no symptoms of illness. (note: this was the first test that i have ever had, never tested before) immediately following the swab my nose began to tingle and within one hour, my nose was plugging up, my sinuses felt full and my ears were plugged. One week later, (b)(6) 2022, i submitted to the weekly swab test as required for employment and tested positive for a virus. Mandated nasal swab to maintain employment.
 
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Brand NameBINAXNOW COVID-19 AG CARD
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
ABBOTT
MDR Report Key13618673
MDR Text Key286336153
Report NumberMW5107736
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 02/24/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 02/25/2022 Patient Sequence Number: 1
Treatment
D3/K2; VIT C; ZINC
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