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

Lot Number (10)221CO20214

Device Problem Material Discolored (1170)

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

Event Date 06/27/2022

Event Type  malfunction  

Event Description

I opened an ihealth covid-19 testing kit and found that the nasal swab had a discolored dot on the swab.I haven't used or opened the swab and got another test kit to complete my testing.Fda safety report id # (b)(4).

• Brand Name: COVID-19 ANTIGEN RAPID 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: 14874323
• MDR Text Key: 295126297
• Report Number: MW5110609
• 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: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/12/2022
• Device Lot Number: (10)221CO20214
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2022
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White