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

Lot Number 221CO20217

Device Problem Expiration Date Error (2528)

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

Event Date 01/15/2023

Event Type  malfunction  

Event Description

Received our free ihealth covid19 tests, they are all expired.

• Brand Name: IHEALTH COVID-19 RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH MANUFACTURING INC
• MDR Report Key: 16195005
• MDR Text Key: 307679614
• Report Number: MW5114349
• 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: 01/15/2023

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 Expiration Date: 08/16/2022
• Device Lot Number: 221CO20217
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2023
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Race: White