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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCABOROUGH BINAXNOW COVID-19 HOME TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

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ABBOTT DIAGNOSTICS SCABOROUGH BINAXNOW COVID-19 HOME TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 Back to Search Results
Catalog Number 195-160
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2021
Event Type  Injury  
Manufacturer Narrative
The remainder of the investigation remains in progress. A supplemental report will be provided after completion.
 
Event Description
The user reported when adding drops from the dropper bottle, some of the liquid squirted to the user's wife's eye.
 
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Brand NameBINAXNOW COVID-19 HOME TEST
Type of DeviceLATERAL FLOW IMMUNOASSAY IVD OF COVID-19
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCABOROUGH
10 southgate road
scarborough ME 04074
Manufacturer Contact
kindra sudduth
10 southgate road
scarborough, ME 04074
6613888803
MDR Report Key12587203
MDR Text Key275139140
Report Number1221359-2021-03083
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00811877011408
UDI-Public01008118770114081722020410148988
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA202537
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number195-160
Device Lot Number148988
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Date Manufacturer Received04/13/2022
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: 10/06/2021 Patient Sequence Number: 1
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