MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 ANTIGEN SELF TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Catalog Number 195160

Device Problem Use of Device Problem (1670)

Patient Problem Eye Burn (2523)

Event Date 12/10/2021

Event Type  malfunction  

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.

Event Description

The consumer reported accidentally splashing the reagent solution into the eyes for the binaxnow covid-19 antigen self test otc test on (b)(6) 2021.The consumer reported swollen and slightly irritated eye lids.The consumer was advised to wash his eyes immediately with copious amounts of water and to seek medical advice with his healthcare provider.A copy of the reagent solution sds was provided to the consumer.

Manufacturer Narrative

Technical services provided the customer with the relevant safety data sheets.A product deficiency was not identified and no further action is required.Based on the above summary, the investigation is deemed complete.The product will continue to monitored and tracked.

• Brand Name: BINAXNOW COVID-19 ANTIGEN SELF TEST
• 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: 13227166
• MDR Text Key: 283613526
• Report Number: 1221359-2022-00165
• 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: 05/02/2022

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: 195160
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 04/15/2022
• Supplement Dates FDA Received: 05/04/2022
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian