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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCABOROUGH BINAXNOW COVID-19 HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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ABBOTT DIAGNOSTICS SCABOROUGH BINAXNOW COVID-19 HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Catalog Number 195-160
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Nodule (4551)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress. A supplemental report will be provided after completion.
 
Event Description
The user reported via web submission a pea-sized lump in the inner part of the right eye on the nose after using the binaxnow covid-19 antigen self test.
 
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Brand NameBINAXNOW COVID-19 HOME TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
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 Key12817310
MDR Text Key280804598
Report Number1221359-2021-03245
Device Sequence Number1
Product Code QKP
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 04/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2021
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 Received04/15/2022
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

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