MAUDE Adverse Event Report: COVID-19 ANTIGEN TESTS; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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

Patient Problems Nausea (1970); Malaise (2359); Weight Changes (2607)

Event Date 09/30/2021

Event Type  Injury  

Event Description

I believe i am getting sick from covid antigen tests.I got really sick after each test that included flu-like symptoms, body aches, lost weight, couldn't eat, no appetite.I went to (b)(6) to get rapid antigen covid19 tests.Location of (b)(6) is in (b)(6) and they conducted the test outside.I had two tests done for dates (b)(6) 2021 and (b)(6) 2021 and got sick both times the day after getting the test.Before the test was completed, i did not have any covid19 symptoms and was getting the test in order to go to an event.I did not go to the physician after getting symptoms- i self managed at home.(b)(6) was the testing facility- i do not have the actual test.Fda safety report id # (b)(4).

• Brand Name: COVID-19 ANTIGEN TESTS
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 12727861
• MDR Text Key: 279551646
• Report Number: MW5105029
• Device Sequence Number: 1
• Product Code: QKP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/28/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• 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: 59 YR