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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 ANTIGEN SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 ANTIGEN SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 Back to Search Results
Catalog Number 195-160
Device Problem Use of Device Problem (1670)
Patient Problem Eye Burn (2523)
Event Date 12/14/2021
Event Type  Injury  
Manufacturer Narrative
This investigation is still in progress. Once the investigation is complete a supplemental report will be provided.
 
Event Description
The consumer reported accidentally getting reagent solution from the binaxnow covid-19 antigen self test in both eyes. She has a burning sensation and dry sensation in her eyes. She has been washing her eyes with water since the exposure. She mistook the solution for her eye drops and applied it to both eyes. (b)(6) connected the consumer to (b)(6) poison control. A safety data sheet (sds) was provided via email.
 
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Brand NameBINAXNOW COVID-19 ANTIGEN SELF TEST
Type of DeviceLATERAL FLOW IMMUNOASSAY IVD OF COVID-19
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
10 southgate road
scarborough ME 04074
Manufacturer Contact
rachel blackwell
10 southgate road
scarborough, ME 04074
MDR Report Key13175593
MDR Text Key283302391
Report Number1221359-2022-00057
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA210264
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number195-160
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/25/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/06/2022 Patient Sequence Number: 1
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