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

Patient Problem Vomiting (2144)

Event Date 08/13/2023

Event Type  Injury  

Event Description

My father is in a nursing facility.He started vomiting clear greenish fluid at 1 am today.The only thing that changed is he was administered 2 eua covid nose swabs in the last 2 or 3 days.Other residents are having this same symptom.The whole facility was put on a covid outbreak watch about 3 days ago when it was reported that one resident tested positive.They also are force-masking on these elderly patients.Masks are also under eua.I believe the nose swabs caused the worsening new symptom as an adverse reaction.I have guardianship over my father.The tests and masks were administered without my informed consent, which is part of the federal food & drug act for eua medical devices.I want the test kits and masks investigated, as well as the facility.I was not informed of covid protocols when i signed admittance contracts, so was denied opportunity to give informed consent.The facility is a nursing home: (b)(6).Nurse who reported symptom to me was dina at about 2 am.She also reported that other residents have also developed this new symptom with concurrent negative covid test nose swab results.2 nose swabs were administered without my knowledge or consent.Results were neg.Other patients also have this same symptom it was reported to me.Covid test; check with nursing facility.Masks, please check with facility.Reference reports: mw5144618, mw5144619.Refer to additional documents in i2k.

• Brand Name: COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17560040
• MDR Text Key: 321346785
• Report Number: MW5144617
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 08/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White