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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 Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problem Insufficient Information (4580)
Event Date 06/26/2023
Event Type  malfunction  
Event Description
The consumer reported accidental reagent exposure to the eyes with a binaxnow covid-19 antigen self-test on (b)(6) 2023.Per the consumer, she accidently splashed reagent into her eyes as she was opening the bottle of the reagent.No additional patient information, including treatment and outcome, was provided.
 
Manufacturer Narrative
The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : single-use: device discarded.
 
Event Description
The consumer reported accidental reagent exposure to the eyes with a binaxnow covid-19 antigen self-test on (b)(6) 2023.Per the consumer, she accidently splashed reagent into her eyes as she was opening the bottle of the reagent.No additional patient information, including treatment and outcome, was provided.
 
Manufacturer Narrative
A product deficiency was not reported or found.Technical services was unable to send the customer the reagent safety data sheet as the customer refused to provide their email address.A supplemental report will be provided if any additional 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 Key17260291
MDR Text Key318466486
Report Number1221359-2023-01257
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date12/16/2023
Device Catalogue Number195-160
Device Lot Number188726
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/26/2023
Initial Date FDA Received07/05/2023
Supplement Dates Manufacturer Received07/05/2023
Supplement Dates FDA Received07/07/2023
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;
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