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

Lot Number 154369

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Burning Sensation (2146); Numbness (2415); Lethargy (2560)

Event Date 09/14/2021

Event Type  Injury  

Event Description

Experiencing concerning issues with repeat exposure to abbott binaxnow tests for covid.First two weeks were okay.Starting on third weekly exposure, immediately after testing, i noticed brief burning sensations followed by numbness at the point of contact between the swab and nose.Numbness fades within a few hours.Also experiencing sinus headaches and lethargy occurring within a few hours, that usually subside by the end of the day.Recurrent phantom burning sensations at the point of contact that come and go for 3-5 days after testing.On my sixth test as of today and problems are getting more pronounced with each exposure.Phantom burning sensations seem to last longer with each test.Fda safety report id # (b)(4).

• Brand Name: BINAXNOW
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 12589822
• MDR Text Key: 275423714
• Report Number: MW5104435
• Device Sequence Number: 1
• Product Code: QKP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/05/2021
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 154369
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 70