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 Improper or Incorrect Procedure or Method (2017)

Patient Problem Eye Pain (4467)

Event Date 02/10/2023

Event Type  malfunction  

Manufacturer Narrative

Technical service provided the safety data sheet (sds) via email to consumer.The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Device discarded; single-use device.

Event Description

The consumer reported accidental exposure to the binaxnow covid-19 self-test reagent on (b)(6) 2023.Per the consumer, he accidentally splashed the reagent in his eyes.The consumer reported "washing" his eyes with water and stated that his eyes still "facing burning sensation".The consumer was advised to seek medical attention as he is still facing burning sensations.

Event Description

The consumer reported accidental exposure to the binaxnow covid-19 self-test reagent on (b)(6) 2023.Per the consumer, he accidentally splashed the reagent in his eyes.The consumer reported "washing" his eyes with water and stated that his eyes still "facing burning sensation".The consumer was advised to seek medical attention as he is still facing burning sensations.

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 for medication as he is still facing burning sensations.The reported health status is anticipated in nature and severity for binaxnow covid-19 ag card risk documentation.A supplemental report will be provided if any additional is obtained.H1: type of reportable event.H3 other text : device discarded; single-use device.

• 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: 16383152
• MDR Text Key: 309638026
• Report Number: 1221359-2023-00335
• 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: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Device Lot Number: 216444
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2023
• 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 Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 81 KG