MAUDE Adverse Event Report: COVID TEST NASAL; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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

Patient Problems Inflammation (1932); Unspecified Respiratory Problem (4464); Swelling/ Edema (4577)

Event Date 01/08/2022

Event Type  Injury  

Event Description

Covid test jammed up nose-now swelling, inflammation and stuffiness.Was sick early november.Unknown hospital can't even tell.Fda safety report id# (b)(4).

• Brand Name: COVID TEST NASAL
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 13257849
• MDR Text Key: 283957563
• Report Number: MW5106656
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male