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U.S. Department of Health and Human Services

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

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IHEALTH LABS, INC. IHEALTH COVID-19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Lot Number (10): 223CO20220
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Pain (1994); Burning Sensation (2146)
Event Date 07/31/2022
Event Type  Injury  
Event Description
After testing with ihealth covid-19 antigen rapid test, i have severe headaches, red, painful eyes, runny, burning nose. The swab burned during testing. Help me please. Fda safety report id# (b)(4).
 
Event Description
Additional information received from reporter on 11/15/2022 for report mw5111230. This is a followup to my earlier report. My access number is mw5111230. I have continuing eye pain and burning. My vision is deteriorating. I need any additional information you can provide about my report of (b)(6) covid-19 antigen rapid test model ico-3000 to provide to my doctor. I also reported this problem to (b)(6) but received no response.
 
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Brand NameIHEALTH COVID-19 TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
IHEALTH LABS, INC.
150c charcot ave.
san jose CA 95131
MDR Report Key15155901
MDR Text Key297220882
Report NumberMW5111230
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 07/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Expiration Date08/19/2022
Device Lot Number(10): 223CO20220
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 08/02/2022 Patient Sequence Number: 1
Treatment
HYDROCHLOROTHIAZIDE; OMEPRAZOLE; VALACYCLOVIR ; ZOLOFT
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