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

Catalog Number 195-100

Device Problem Use of Device Problem (1670)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 08/03/2022

Event Type  Injury  

Event 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.

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.

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 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
• 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,
• MDR Report Key: 15283713
• MDR Text Key: 298491522
• Report Number: 1221359-2022-04298
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011330
• UDI-Public: 01008118770113301722122110178674
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA203107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/21/2022
• Device Catalogue Number: 195-100
• Device Lot Number: 178674
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic