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

Catalog Number 195-000

Device Problem Use of Device Problem (1670)

Patient Problem Burning Sensation (2146)

Event Date 12/30/2021

Event Type  Injury  

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.

Event Description

The customer reported that the binaxnow covid-19 ag card extraction reagent came into contact with the patient's eyes on (b)(6) 2021.The patient reported a burning sensation after reagent exposure to their eyes.The customer stated that the burning sensation disappeared after the patient applied saline solution to both eyes.The patient reported that she woke up the next day with slight mucus in both eyes.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide investigation conclusion.Customer was provided the safety data sheet (sds).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.The product will continue to be monitored and tracked.

• Brand Name: BINAXNOW COVID-19 AG CARD
• 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 ; 6613888803
• MDR Report Key: 13357712
• MDR Text Key: 284447787
• Report Number: 1221359-2022-00534
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-000
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2022
• 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