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 Material Separation (1562)

Patient Problems Decreased Sensitivity (2683); Epistaxis (4458)

Event Date 01/01/2023

Event Type  Injury  

Event Description

The consumer reported while inserting the nasal swab from the binaxnow covid-19 ag self-test deep into their nasal cavity that the swab broke and a portion of the swab remained stuck in their nasal cavity on an unknown date.The consumer indicated that this caused their nose to bleed and resulted in a loss of smell.It is unknown if the portion of the swab which was stuck was able to be removed but the consumer stated they have not sought medical attention.Although requested, no additional information was received.

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Event date is an approximation as the date of event was not provided.Single use device, discarded.

Event Description

The consumer reported while inserting the nasal swab from the binaxnow covid-19 ag self-test deep into their nasal cavity that the swab broke and a portion of the swab remained stuck in their nasal cavity on an unknown date.The consumer indicated that this caused their nose to bleed and resulted in a loss of smell.It is unknown if the portion of the swab which was stuck was able to be removed but the consumer stated they have not sought medical attention.Although requested, no additional information was received.

Manufacturer Narrative

The customer reported a few months ago they were injured while using the binaxnow covid-19 binaxnow covid-19 test.The customer stated they inserted the swab deeply into the nasal cavity to gather the sample.The customer stated the swab broke during insertion and a portion of the swab remained in the nasal cavity, which caused their nose to bleed.The customer stated as a result of this incident they have lost their sense of smell.The customer stated they did not seek medical attention for this at the time or since then.The information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, complaints against these trend codes are monitored to identify and track any out-of-trend/unexpected performance at the lot and product family level.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: 16341552
• MDR Text Key: 309297377
• Report Number: 1221359-2023-00260
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 05/01/2023
• Supplement Dates FDA Received: 05/02/2023
• 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: 37 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White