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 Skin Burning Sensation (4540)

Event Date 10/03/2023

Event Type  malfunction  

Event Description

The consumer reported accidental exposure to the binaxnow covid-19 self-test reagent on (b)(6) 2023.Per the consumer, she had reagent on the swab and inserted the swab into both of her nostrils.The consumer stated she experienced a burning sensation inside her nose but after rinsing her nose with water, the burning sensation subsided.The customer confirmed there was no serious injury or harm due to the reagent exposure.Additionally, the consumer confirmed there was no delay or impact in treatment.

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 the burning sensation or irritation persisted.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.

• 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: 17997997
• MDR Text Key: 326558426
• Report Number: 1221359-2023-01571
• 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
• Report Date: 10/24/2023

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 Catalogue Number: 195-160
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/24/2023
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White