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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 Red Eye(s) (2038); Eye Burn (2523)
Event Date 12/14/2021
Event Type  Injury  
Manufacturer Narrative
This investigation is still in progress. Once the investigation is completed, a supplemental report will be provided.
 
Event Description
The consumer reported that the extraction reagent from the binaxnow covid-19 antigen self test came in contact with the eyes on (b)(6) 2021. The consumer spoke with technical services (ts) and stated that he rinsed his eyes for five minutes, the consumer stated he was experiencing eye redness and stinging. Ts connected the patient with a local poison and drug services line for further medical advice on how to proceed. Due to privacy reasons ts had to release the call once the consumer was connected to a specialist at the local poison and drug services center. No additional patient information, including treatment and outcome, was provided.
 
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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 Key13211802
MDR Text Key283576582
Report Number1221359-2022-00018
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 05/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2022
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 Received04/15/2022
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

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