MAUDE Adverse Event Report: PCR TEST; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Headache (1880); Unspecified Respiratory Problem (4464)

Event Date 07/14/2022

Event Type  Injury  

Event Description

I took a pcr test that is required weekly by my employer.My nostrils have been sore frequently after testing.This time i have a headache as well.Fda safety report id# (b)(4).

• Brand Name: PCR TEST
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• MDR Report Key: 15054325
• MDR Text Key: 296215792
• Report Number: MW5110935
• Device Sequence Number: 1
• Product Code: QJR
• 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: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: A MULTIVITAMIN DAILY; VITAMIN D, C A FEW TIMES A WEEK
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Hispanic
• Patient Race: White