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 Burning Sensation (2146)

Event Date 06/15/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.H3 other text : device discardedr, single use.

Event Description

The consumer reported on putting the reagent in the nose with binaxnow covid-19 ag self-test on (b)(6)2023.Per the consumer, she accidentally dipped the swab on the top hole with the reagent and put it inside her nose (both nostrils).The consumer had a mild burning sensation which subsided after the consumer rinsed their nose with water.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

Intake user reached out to the customer to see if they needed the sds sheet and the customer refused the sds document.The reported health status is anticipated in nature and severity for binaxnow covid-19 ag card risk documentation.No additional investigation is necessary as a product deficiency was not identified.

Event Description

The consumer reported on putting the reagent in the nose with binaxnow covid-19 ag self-test on 15jun2023.Per the consumer, she accidentally dipped the swab on the top hole with the reagent and put it inside her nose (both nostrils).The consumer had a mild burning sensation which subsided after the consumer rinsed their nose with water.No additional patient information, including treatment and outcome, was provided.

• 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: 17153871
• MDR Text Key: 317853367
• Report Number: 1221359-2023-01217
• 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: 06/23/2023

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
• Device Lot Number: 217811
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 06/19/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 06/23/2023
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White