MAUDE Adverse Event Report: SARS-COV-2 PCR TEST; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Burning Sensation (2146)

Event Date 10/07/2021

Event Type  Injury  

Event Description

As a health care professional who is unvaccinated against covid-19 i am subjected to weekly testing to retain my career.Each week i develop headaches after testing and have noticed with each test that a burning sensation increases with each test.I am also 14 weeks pregnant and am concerned about the side effects increasing weekly.Fda safety report id# (b)(4).

• Brand Name: SARS-COV-2 PCR TEST
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC
• MDR Report Key: 12664795
• MDR Text Key: 277682268
• Report Number: MW5104760
• Device Sequence Number: 1
• Product Code: QJR
• 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: 10/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR