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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW AG TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW AG TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Lot Number 143927
Device Problems Material Discolored (1170); Device Emits Odor (1425)
Patient Problems Sneezing (2251); Caustic/Chemical Burns (2549)
Event Date 09/01/2021
Event Type  Injury  
Event Description
Binaxnow ag test use for covid-19 under emergency use authorization. (eua): binaxnow ag test kit, lot # 143927, expiration date of 09/23/2021. On (b)(6) 2021, individual utilized a swab from the box of test kits indicated to swab herself. At the time that she swabbed herself, she told the nurse that the swab had a "very strong odor". On (b)(6) 2021, individual notified the facility that she had received "chemical burns" in her nostrils, indicating it was from the swab. When asked about the swab, she stated that she noticed it had a "yellow" color to it and had a very strong odor. (the nurse that provided the swab to the individual did not notice a discoloring or odor), individual indicated that she watched the nurse open the packet containing the swab and he did not lay it down anywhere prior to handing it to her. Individual stated that following the swab, she had a large amount of nasal drainage and sneezing. Stated that she went to a medical provider who indicated she has "chemical burns" in her nasal area. Facility had used the full box prior to being notified by this individual. There have been no other negative/adverse reaction reported. (as a matter of fact, we have 12 long term care facilities utilizing these kits and we have had no other negative/adverse reactions at all. ).
 
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Brand NameBINAX NOW AG TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
MDR Report Key12438495
MDR Text Key270615263
Report NumberMW5103742
Device Sequence Number1
Product Code QKP
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/23/2021
Device Lot Number143927
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/07/2021 Patient Sequence Number: 1
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