MAUDE Adverse Event Report: IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number ICO-3000

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

Patient Problems Numbness (2415); Taste Disorder (4422); Swelling/ Edema (4577)

Event Date 07/09/2022

Event Type  Injury  

Event Description

I took the ihealth covid-19 antigen rapid test, which i obtained free of charge from the government.45-minutes after taking the test my tongue started tingling.A few minutes later my tongue, and lips started swelling.The area directly below my lower lip started swelling and my bottom teeth became numb feeling.I also had a strange taste in my mouth.I do have an auto-immune disease and non-hogdkins follicular b-cell lymphoma.My son took 1 test, and i took the other.He did not have any issues, but i saved both tests that came out of the same box.Fda safety report id# (b)(4).

• Brand Name: IHEALTH COVID-19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC.; 150c charcot ave; san jose CA 95131
• MDR Report Key: 15001594
• MDR Text Key: 295896456
• Report Number: MW5110807
• 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: 07/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/23/2022
• Device Model Number: ICO-3000
• Device Lot Number: (10):213CO21224-08
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: COLLOIDAL SILVER; HYDROCODONE/ACETAMINOPHEN; MAGNESIUM PO; METOPROLOL SUCCINATE ER; MULTIPLE VITAMIN; OMEPRAZOLE DR; TRAZODONE
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White