MAUDE Adverse Event Report: HOME RAPID ANTIGEN TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Meningitis (2389)

Event Date 02/22/2022

Event Type  Death  

Event Description

Lacking warnings and risks.The following notice is missing required risk of injury and death information as required by food drug cosmetics act, prep act, and 18 us code 241, 18 us code 242 and the united states constitution duty to protect: https://www.Fda.Gov/media/153922/download.There is no listing of deaths.One woman in (b)(6) was swabbed and died of meningitis 20 days later.The fda is out of compliance with the law.Fda safety report id # (b)(4).

• Brand Name: HOME RAPID ANTIGEN TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 13599679
• MDR Text Key: 286343160
• Report Number: MW5107695
• 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: Unknown
• Type of Report: Initial
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other