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 Red Eye(s) (2038)

Event Date 09/22/2022

Event Type  Injury  

Event Description

The consumer reported accidental eye exposure with the binaxnow covid-19 antigen self-test reagent on (b)(6) 2022.Due to the accidental exposure, the patient reportedly experienced eye redness and a burning sensation.The consumer rinsed his eyes and was put in contact with the local poison control.

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Single-use; device discarded.

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 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 eye exposure with the binaxnow covid-19 antigen self-test reagent on (b)(6) 2022.Due to the accidental exposure, the patient reportedly experienced eye redness and a burning sensation.The consumer rinsed her eyes and was put in contact with the local poison control.

• 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: 15579673
• MDR Text Key: 301497771
• Report Number: 1221359-2022-10005
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

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 Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 12/19/2022
• 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