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

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

Patient Problem No Code Available (3191)

Event Date 06/30/2020

Event Type  Injury  

Event Description

I had the state mandated covid 19 test for work.After the test i noticed that my left nostril felt plugged (test completed using left side).I assumed it was due to swelling from the test, but it has not resolved.Fda safety report id# (b)(4).

• Brand Name: COVID 19- NASOPHARYNGEAL TEST
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• MDR Report Key: 10244611
• MDR Text Key: 198096075
• Report Number: MW5095396
• 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: 07/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 47 YR
• Patient Weight: 181