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

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.

• Brand Name: IHEALTH COVID-19 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: 15155901
• MDR Text Key: 297220882
• Report Number: MW5111230
• 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,Followup
• Report Date: 07/31/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/19/2022
• Device Lot Number: (10): 223CO20220
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: HYDROCHLOROTHIAZIDE; OMEPRAZOLE; VALACYCLOVIR ; ZOLOFT
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White