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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 Problems Eye Burn (2523); Eye Pain (4467)
Event Date 06/24/2022
Event Type  malfunction  
Manufacturer Narrative
Technical service provided the safety data sheet to the customer and no further action is required. According to the package insert in195150c v. 3. 0. Precautions 20. The reagent solution contains a harmful chemical (see table below). If the solution contacts the skin or eye, flush with copious amounts of water. If irritation persists, seek medical advice: https://www. Poison. Org/contact-us or 1-800-222-1222. Based on the above summary, the investigation is deemed complete. The product will continue to be monitored and tracked.
 
Event Description
The consumer reported exposing his eyes to the extraction reagent of the binaxnow covid-19 antigen self test after mistakenly using the extraction reagent as eye drops. The consumer reported experiencing discomfort and burning sensation.
 
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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
6613888803
MDR Report Key15002959
MDR Text Key304691087
Report Number1221359-2022-03582
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
Report Date 07/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2022
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
Date Manufacturer Received06/26/2022
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: 07/13/2022 Patient Sequence Number: 1
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