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

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bacterial Infection (1735); Localized Skin Lesion (4542)

Event Date 10/05/2021

Event Type  Injury  

Event Description

Required to take weekly covid test by (b)(6).Diagnosed with lesion in nostril and staph infection.Ent provider had to prescribe antibiotic.

• Brand Name: COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 16902751
• MDR Text Key: 314983498
• Report Number: MW5117410
• 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: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female