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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 CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 ANTIGEN SELF TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Catalog Number 195160
Device Problem Use of Device Problem (1670)
Patient Problem Eye Burn (2523)
Event Date 12/10/2021
Event Type  malfunction  
Manufacturer Narrative
The remainder of the investigation remains in progress. A supplemental report will be provided after completion.
 
Event Description
The consumer reported accidentally splashing the reagent solution into the eyes for the binaxnow covid-19 antigen self test otc test on (b)(6) 2021. The consumer reported swollen and slightly irritated eye lids. The consumer was advised to wash his eyes immediately with copious amounts of water and to seek medical advice with his healthcare provider. A copy of the reagent solution sds was provided to the consumer.
 
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Brand NameBINAXNOW COVID-19 ANTIGEN SELF TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
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 Key13227166
MDR Text Key283613526
Report Number1221359-2022-00165
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 05/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number195160
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Date Manufacturer Received04/15/2022
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: 01/11/2022 Patient Sequence Number: 1
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