MAUDE Adverse Event Report: COVID-19 TEST KIT; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Lot Number ALCR-1187

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Dizziness (2194); Taste Disorder (4422)

Event Date 11/10/2021

Event Type  Injury  

Event Description

After appropriately using the color covid-19 test kit, i had an odd taste in the back of my throat, light-headedness, and a pressure headache.Fda safety report id # (b)(4).

Event Description

Add'l info received on 12/02/2021.Fda safety report id# (b)(4).

Event Description

Additional information received for mw5105291 on 12/03/2021.Fda safety report id # (b)(4).

• Brand Name: COVID-19 TEST KIT
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• MDR Report Key: 12813176
• MDR Text Key: 280817764
• Report Number: MW5105291
• 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,Followup,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/31/2022
• Device Lot Number: ALCR-1187
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White