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 Use of Device Problem (1670)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 01/05/2023

Event Type  Injury  

Event Description

The consumer reported accidental exposure to the binaxnow covid-19 self-test reagent on (b)(6) 2023.Per the consumer, she struggled to open the provided dropper of reagent and while "snapping the nozzle of the dropper" she "spilled" reagent into her eyes.The consumer reported rinsing her eyes for five (5) minutes with water before wiping them.She also reported her eyes "feeling like they had a coating" but stated that she felt no irritation.The consumer was advised via phone to rinse her eyes under running water and contact a healthcare provider to ensure that proper treatment is administered.

Manufacturer Narrative

Technical services provided the safety data sheet to the customer.The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Single use; device discarded.

Manufacturer Narrative

D4 - expiration date.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.H3 other text : single use; device discarded.

Event Description

The consumer reported accidental exposure to the binaxnow covid-19 self-test reagent on 05jan2023.Per the consumer, she struggled to open the provided dropper of reagent and while "snapping the nozzle of the dropper" she "spilled" reagent into her eyes.The consumer reported rinsing her eyes for five (5) minutes with water before wiping them.She also reported her eyes "feeling like they had a coating" but stated that she felt no irritation.The consumer was advised via phone to rinse her eyes under running water and contact a healthcare provider to ensure that proper treatment is administered.

• 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: 16157556
• MDR Text Key: 307284148
• Report Number: 1221359-2023-00077
• 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: 03/17/2023

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 Operator: Lay User/Patient
• Device Expiration Date: 05/14/2024
• Device Catalogue Number: 195-160
• Device Lot Number: 214296
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 03/14/2023
• Supplement Dates FDA Received: 03/17/2023
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White