MAUDE Adverse Event Report: COVID-19 TEST; REAGENT, CORONAVIRUS SEROLOGICAL

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

Patient Problems Headache (1880); Tingling (2171); Numbness (2415); Palpitations (2467)

Event Date 06/03/2020

Event Type  No Answer Provided  

Event Description

After receiving covid-19 test i noticed that my heart was racing.Within minutes i also had a slight headache.Within an hour, the roof of my mouth was numb, as was my tongue.Three hours later, my nose and sinuses are tingling, and a feeling of being tired and 'thick-headed', 'loopy or woozy.' test was received at (b)(6) drive-through test site.Did the problem stop after the person reduced the dose or stopped taking or using the product? yes; did the problem return if the person started taking or using the product again? yes.Quantity: 2, 1st = 10 sec; 2nd = 30.Frequency: 1 time per week; swab in each nasal passage.Date the person first started taking or using the product: (b)(6) 2020; date the person stopped taking or using the product: (b)(6) 2020."covid-19 test -required for employment.Am to repeat each week.".

• Brand Name: COVID-19 TEST
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• MDR Report Key: 10200018
• MDR Text Key: 196769848
• Report Number: MW5095221
• Device Sequence Number: 1
• Product Code: QKO
• 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: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 78