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

Model Number ICO-300

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2022

Event Type  malfunction  

Event Description

My government free tests received in mail, were all incomplete, missing small tube of "sealed solution" so i could not follow directions, and did not take tests.Had to seek another test.Had to drive around to hunt for test when i wasn't feeling well.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.; 120 san lucar ct; sunnyvale CA 94086
• MDR Report Key: 14218590
• MDR Text Key: 290275039
• Report Number: MW5109366
• 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
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/08/2022
• Device Model Number: ICO-300
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALLENDRONATE; MULTIVITAMIN
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White