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U.S. Department of Health and Human Services

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

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IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
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).
 
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Brand NameIHEALTH COVID-19 ANTIGEN RAPID TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
IHEALTH LABS, INC.
150c charcot ave
san jose CA 95131
MDR Report Key15001594
MDR Text Key295896456
Report NumberMW5110807
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received07/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Expiration Date06/23/2022
Device Model NumberICO-3000
Device Lot Number(10):213CO21224-08
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 07/12/2022 Patient Sequence Number: 1
Treatment
COLLOIDAL SILVER; HYDROCODONE/ACETAMINOPHEN; MAGNESIUM PO; METOPROLOL SUCCINATE ER; MULTIPLE VITAMIN; OMEPRAZOLE DR; TRAZODONE
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