MAUDE Adverse Event Report: ABBOTT BINAXNOW COVID-19 AG CARD; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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

Patient Problems Viral Infection (2248); Unspecified Respiratory Problem (4464); Unspecified Ear or Labyrinth Problem (4474)

Event Date 02/15/2022

Event Type  Injury  

Event Description

Nasal/auditory/sinus effect.I submitted to a nasal swab test as mandated for a select group of employees.I was not ill and showed no symptoms of illness.(note: this was the first test that i have ever had, never tested before) immediately following the swab my nose began to tingle and within one hour, my nose was plugging up, my sinuses felt full and my ears were plugged.One week later, (b)(6) 2022, i submitted to the weekly swab test as required for employment and tested positive for a virus.Mandated nasal swab to maintain employment.

• Brand Name: BINAXNOW COVID-19 AG CARD
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 13618673
• MDR Text Key: 286336153
• Report Number: MW5107736
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• 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: 02/24/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2022
• Patient Sequence Number: 1
• Treatment: D3/K2; VIT C; ZINC
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White