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

Catalog Number 195-160

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.

Event Description

The consumer behalf of her daughter reported adverse reactions after using binaxnow¿ covid-19 antigen self test performed on (b)(6) 2021.Consumer stated that after swabbing the nose she experienced burning sensation , dizziness , pain in nose and headache.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

Technical services provided customer with the relevant safety data sheets for the product.A product deficiency was not identified and no further action is required.Based on the above summary the investigation is deemed complete.The product will continue to be monitored and tracked.

Manufacturer Narrative

The supplemental report is being submitted to correct the previously reported event.Please see updates: d1, d2, d3, d9, g1,g3, g6 and h2.Corrections: d1,& d2 additional information: d3, d9 & g1.

• Brand Name: BINAXNOW COVID-19 AG CARD
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: venkat dakoju ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 12526169
• MDR Text Key: 274774611
• Report Number: 1221359-2021-02848
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA202537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2022
• 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 Sex: Female