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U.S. Department of Health and Human Services

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

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Lot Number 154369
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Burning Sensation (2146); Numbness (2415); Lethargy (2560)
Event Date 09/14/2021
Event Type  Injury  
Event Description
Experiencing concerning issues with repeat exposure to abbott binaxnow tests for covid. First two weeks were okay. Starting on third weekly exposure, immediately after testing, i noticed brief burning sensations followed by numbness at the point of contact between the swab and nose. Numbness fades within a few hours. Also experiencing sinus headaches and lethargy occurring within a few hours, that usually subside by the end of the day. Recurrent phantom burning sensations at the point of contact that come and go for 3-5 days after testing. On my sixth test as of today and problems are getting more pronounced with each exposure. Phantom burning sensations seem to last longer with each test. Fda safety report id # (b)(4).
 
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Brand NameBINAXNOW
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
MDR Report Key12589822
MDR Text Key275423714
Report NumberMW5104435
Device Sequence Number1
Product Code QKP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/05/2021
6 Devices were Involved in the Event: 1   2   3   4   5   6  
0 Patients were Involved in the Event:
Date FDA Received10/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number154369
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
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

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