MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG CARD HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number	195-100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146)
Date of Event	08/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The consumer reported having a severe allergic reaction to foamtech medical nasal swab from binaxnow covid-19 ag home test.The patient reported a very painful reaction upon inserting the swab into their nose.The patient reportedly experienced a tingling feeling that developed into an intense burning sensation in the throat.Intense additionally, the pain caused the patient to heave.The patient reportedly went to the emergency room after completing the test.The patient had no known allergies and did not conduct any allergic testing.The patient reportedly uses a nasal spray daily.Although requested, details of the emergency room visit were not provided.
Additional Manufacturer Narrative
This report is being submitted for the initial and investigation completion.Technical services advised the customer to seek medical attention if the allergic reaction proceeds.Technical services emailed the customer the foamtech medical safety data sheet.Technical services provided the customer the detailed methodology for the sterilization processes of the kit swabs.The reported health status is anticipated in nature and severity for binaxnow covid-19 ag card risk documentation.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the updated emergency room information and investigation conclusion.The reported health status is anticipated in nature and severity for binaxnow covid-19 ag card risk documentation.Technical services advised the customer to seek medical attention if the allergic reaction proceeds.Technical services emailed the customer the foamtech medical safety data sheet.Technical services provided the customer the detailed methodology for the sterilization processes of the kit swabs.The current overall incident rate for side effect/reaction to the sample collection for this specific kit lot and swab lot based on the total distributed devices is (b)(4).A supplemental report will be provided if any additional is obtained.The product will continue to be monitored and tracked.
Event or Problem Description
The emergency room diagnosed the patient with dyspnea from the test swab.The consumer was treated with an epinephrine injection.

• Brand Name: BINAXNOW COVID-19 AG CARD HOME TEST
• Common Device Name: 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,
• MDR Report Key: 15283713
• Report Number: 1221359-2022-04298
• Device Sequence Number: 11388890
• Product Code: QKP
• UDI-Device Identifier: 00811877011330
• UDI-Public: 01008118770113301722122110178674
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EUA203107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/21/2022
• Device Catalogue Number: 195-100
• Device Lot Number: 178674
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic