MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 ANTIGEN SELF TEST; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number 195-160

Device Problem Insufficient Information (3190)

Patient Problem Epistaxis (4458)

Event Type  Injury  

Event Description

The consumer reported a burning sensation after 15 minutes of swabbing the nose with the binaxnow covid-19 antigen self test.The consumer also reported a bloody nose after 4 hours of swabbing.Although requested, additional information, including patient treatment and outcome was not provided.

Manufacturer Narrative

This investigation is still in progress.Once the investigation is complete a supplemental report will be provided.

Manufacturer Narrative

Investigation report: technical service provided the safety data sheet to the customer.The information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, complaints against these trend codes are monitored to identify and track any out-of-trend/unexpected performance at the lot and product family level.The product will continue to be monitored and tracked.

• Brand Name: BINAXNOW COVID-19 ANTIGEN SELF TEST
• Type of Device: LATERAL FLOW IMMUNOASSAY IVD OF 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
• MDR Report Key: 13042700
• MDR Text Key: 282488078
• Report Number: 1221359-2021-03749
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 05/26/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White