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

Catalog Number 195-160

Device Problem Use of Device Problem (1670)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 03/31/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The consumer reported on buffer solution poured in the eye with binaxnow covid-19 home test reagent on (b)(6) 2022.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 (sds).A doctor from abbott called the customer and found out patient is doing fine.

• Brand Name: BINAXNOW COVID-19 SELF-TEST
• 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
• MDR Report Key: 14196716
• MDR Text Key: 291213923
• Report Number: 1221359-2022-02122
• Device Sequence Number: 1
• Product Code: QKP
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 195-160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 05/10/2022
• Supplement Dates FDA Received: 05/25/2022
• 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: Male