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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 Device Handling Problem (3265)
Patient Problems Conjunctivitis (1784); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2023
Event Type  malfunction  
Event Description
Consumer reported reagent contact with eyes while performing binaxnow covid-19 ag self test on (b)(6) 2023.Consumer mistook the reagent bottle for eyes drops and put some on her eyes and she had eye irritation.No additional information, including treatment and outcome, was provided.
 
Manufacturer Narrative
The investigation is still in progress.A supplemental report will be provided after completion.Single use device, device discarded.
 
Event Description
Consumer reported reagent contact with eyes while performing binaxnow covid-19 ag self test on (b)(6) 2023.Consumer mistook the reagent bottle for eyes drops and put some on her eyes and she had eye irritation.No additional information, including treatment and outcome, was provided.
 
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.H6-health effect impact code h3 other text : single use device, 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 Key16574961
MDR Text Key311700283
Report Number1221359-2023-00521
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00811877011408
UDI-Public00811877011408
Combination Product (y/n)N
PMA/PMN Number
EUA210264
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2023
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 Received05/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 SexFemale
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