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

Device Problem Device Emits Odor (1425)

Patient Problem Headache (1880)

Event Date 09/30/2021

Event Type  Injury  

Event Description

After using the binaxnow nasal swab, i suffered a migraine for the rest of the evening.I noticed a smell in my nose immediately after swabbing.Fda safety report id # (b)(4).

• Brand Name: BINAXNOW RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 12681461
• MDR Text Key: 278120487
• Report Number: MW5104833
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 50