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

Model Number ICO-3000

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Swelling/ Edema (4577)

Event Date 01/26/2022

Event Type  Injury  

Event 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
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
• Manufacturer (Section D): IHEALTH LABS, INC.
• MDR Report Key: 13471969
• MDR Text Key: 285253675
• Report Number: MW5107221
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00856362005890
• UDI-Public: 856362005890
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2022
• Patient Sequence Number: 1
• Treatment: MAGNESIUM; MULTIVITAMIN; OMEGA 3; VIT D3
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White