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 Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/10/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The consumer reported that they inadvertently put extraction reagent from the binaxnow covid-19 ag card product into their left eye after mistaking it for eye drops on (b)(6) 2021.They experienced a burning sensation and immediately flushed the eye with water.The consumer was provided the safety data sheet (sds) and was connected via conference call to rocky mountain poison and drug safety.

Manufacturer Narrative

Additional data: h10 technical services provided the user the safety data sheet of the reagent through email.A supplemental report will be provided if any additional is obtained.

• 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: elissa zavorotny ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 12580381
• MDR Text Key: 274911057
• Report Number: 1221359-2021-02942
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• 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: 04/20/2022
• 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