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

Device Problem Output Problem (3005)

Patient Problems Headache (1880); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/07/2021

Event Type  Injury  

Event Description

I submitted to a covid test under duress because i had bloody stool and couldn't get the colonoscopy done unless i submitted under duress for the covid test.My test was done on thursday (b)(6) 2021.I had a severe headache, earaches, and clear drainage from my nose and eyes for 2 days after the test.I was told to show up for my procedure on the 11th unless i got a call regarding a positive result.I didn't hear anything so i did the bowel prep which i paid (b)(6) for out of pocket and showed up for my procedure on monday morning the 11th.They didn't have my covid test results even though i had the test done at their facility per their instructions.They refused to do the colonoscopy on my unless i submitted for another covid test.I begged them to do the colonoscopy that already was delayed because of covid.I had a gi consult in 2019 and the doctor put me at the back of the line for a colonoscopy in (b)(6) of 2020 which was later canceled and meanwhile my symptoms accelerated.I begged the nurse to ask the doctor to please do the colonoscopy that i have active rectal bleeding.They denied me care because i declined a second harmful covid test that isn't even fully approved.I found a new doctor and got my colonoscopy on (b)(6) and was diagnosed with stage 3 rectal cancer.I never got the results of this test that was really an assault and a crime.(b)(6).Fda safety report id# (b)(4).

• Brand Name: COVID 19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 13110880
• MDR Text Key: 282972787
• Report Number: MW5106311
• 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: 12/25/2021

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: 12/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Other
• Patient Age: 48 YR
• Patient Sex: Female