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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Catalog Number 195-160
Device Problem Use of Device Problem (1670)
Patient Problems Red Eye(s) (2038); Eye Pain (4467)
Event Date 09/23/2022
Event Type  Injury  
Manufacturer Narrative
The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Single-use; device discarded.
 
Event Description
The consumer reported accidental exposure to the binaxnow covid-19 antigen self-test reagent on (b)(6) 2022.The consumer reportedly mistook the reagent for eye drops and added several drops to his eye.Due to the accidental exposure, the patient experienced eye redness and a stinging pain.The consumer rinsed his eyes for 5 seconds and used eye drops and was put in contact with rocky mountain poison and drug services.
 
Event Description
The consumer reported accidental exposure to the binaxnow covid-19 antigen self-test reagent on (b)(6) 2022.The consumer reportedly mistook the reagent for eye drops and added several drops to his eye.Due to the accidental exposure, the patient experienced eye redness and a stinging pain.The consumer rinsed his eyes for 5 seconds and used eye drops and was put in contact with rocky mountain poison and drug services.
 
Manufacturer Narrative
A product deficiency was not reported or found.Technical service provided the safety data sheet and advised the consumer to contact their health provider if any irritation occurred.A supplemental report will be provided if any additional information is obtained.The reported health status is anticipated in nature and severity for binaxnow covid-19 ag card risk documentation.H3 other text : single-use; device discarded.
 
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Brand Name
BINAXNOW COVID-19 AG SELF TEST 2CT
Type of Device
CORONAVIRUS 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 Key15576799
MDR Text Key301559263
Report Number1221359-2022-10003
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,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number195-160
Was Device Available for Evaluation? No
Date Manufacturer Received12/14/2022
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 Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
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