MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 AG CARD KIT 40T EUA; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number 195-000

Device Problem Use of Device Problem (1670)

Patient Problems Red Eye(s) (2038); Eye Pain (4467)

Event Date 12/06/2022

Event Type  Injury  

Event Description

The customer reported a few drops of reagent solution landed in her eye with the binaxnow covid-19 ag self test on (b)(6) 2022.The customer reported that as a result of being exposed to the reagent, she experienced a red eye and burning sensation.Technical services informed the customer that she needs to wash her eye under running water and sent the customer the safety data sheet for binaxnow¿ covid-19 antigen self-test otc reagent via email.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Device not returned, single use.

Event Description

The customer reported a few drops of reagent solution landed in her eye with the binaxnow covid-19 ag self test on (b)(6) 2022.The customer reported that as a result of being exposed to the reagent, she experienced a red eye and burning sensation.Technical services informed the customer that she needs to wash her eye under running water and sent the customer the safety data sheet for binaxnow¿ covid-19 antigen self-test otc reagent via email.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

A product deficiency was not reported or found.Technical service provided the safety data sheet and advised the consumer to contact their health provider if any irritation occurred.A supplemental report will be provided if any additional information is obtained.The reported health status is anticipated in nature and severity for binaxnow covid-19 ag card risk documentation.

• Brand Name: BINAX NOW COVID-19 AG CARD KIT 40T EUA
• 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: 15990170
• MDR Text Key: 305547386
• Report Number: 1221359-2022-10328
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 10811877011290
• UDI-Public: 10811877011290
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 195-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2022
• 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: 40 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American