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

Model Number	ICO-3000
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Son administered ihealth covid-19 antigen rapid test.Eleven (11) minutes after putting swab in nose his tongue swelled, face and throat swelled.Https://ihealthlabs.Com.Fda safety report id # (b)(4).

• Brand Name: IHEALTH COVID-19 ANTIGEN RAPID TEST
• Common Device Name: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
• Manufacturer (Section D): IHEALTH LABS, INC.
• MDR Report Key: 13471969
• Report Number: MW5107221
• Device Sequence Number: 14533513
• Product Code: QKP
• UDI-Device Identifier: 00856362005890
• UDI-Public: 856362005890
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/14/2022
• Device Model Number: ICO-3000
• Device Lot Number: (10): 211CO21215
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MAGNESIUM; MULTIVITAMIN; OMEGA 3; VIT D3
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White