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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 LATERAL FLOW IMMUNOASSAY IVD COVID-19

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST LATERAL FLOW IMMUNOASSAY IVD COVID-19 Back to Search Results
Catalog Number 195-160
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Numbness (2415); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2021
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress. A supplemental report will be provided after completion.
 
Event Description
The customer reported extraction reagent coming into contact with nose with the binaxnow covid-19 ag self test. Patient had put some binaxnow covid-19 reagent on swab and inserted it up their nose. Customer realized this was incorrect use and wanted to know if this would cause harm. The customer confirmed there was no medical exposures or injuries.
 
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Brand NameBINAXNOW COVID-19 AG SELF TEST
Type of DeviceLATERAL FLOW IMMUNOASSAY IVD 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 Key12633350
MDR Text Key276589873
Report Number1221359-2021-03117
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 05/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2021
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 Answer Provided
Is the Reporter a Health Professional? No
Date Manufacturer Received04/12/2022
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: 10/14/2021 Patient Sequence Number: 1
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