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U.S. Department of Health and Human Services

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

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IHEALTH LABS, INC. I HEALTH COVID-19 CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2022
Event Type  malfunction  
Event Description
I ordered covid tests through the government post office site in early (b)(6) 2022. They arrived around (b)(6) 2022. All 8 are set to expire on 7/13/2022.
 
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Brand NameI HEALTH COVID-19
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
IHEALTH LABS, INC.
150c charcot ave.
san jose CA 95131
MDR Report Key14932926
MDR Text Key295477138
Report NumberMW5110666
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 07/02/2022
8 Devices were Involved in the Event: 1   2   3   4   5   6   7   8  
0 Patients were Involved in the Event:
Date FDA Received07/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided

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