MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number 195-160

Device Problem Use of Device Problem (1670)

Patient Problem Red Eye(s) (2038)

Event Date 12/13/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.Device discarded, single use.

Event Description

The consumer reported on splashing a drop of the binaxnow covid-19 ag reagent in her eye on (b)(6) 2022.Per consumer, she experienced a burning sensation in her eye.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

Technical service provided the poison control number to the customer.Technical service also mentioned the customer should contact their doctor since they reported a burning sensation.Customer was provided the safety data sheet (sds).No additional investigation is necessary as a product deficiency was not identified.Based on the above summary the investigation is deemed complete.The product will continue to be monitored and tracked.H3 other text : device discarded, single use.

Event Description

The consumer reported on splashing a drop of the binaxnow covid-19 ag reagent in her eye on (b)(6) 2022.Per consumer, she experienced a burning sensation in her eye.No additional patient information, including treatment and outcome, was provided.

• Brand Name: BINAXNOW COVID-19 AG SELF TEST 2CT
• 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, ME 04074 ; 6613888803
• MDR Report Key: 15998641
• MDR Text Key: 305640955
• Report Number: 1221359-2022-10342
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 00811877011408
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/09/2023
• Device Catalogue Number: 195-160
• Device Lot Number: 210770
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White