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

Catalog Number ICO-3000

Device Problem Component Missing (2306)

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

Event Date 02/21/2023

Event Type  malfunction  

Event Description

Both solution bottles in the kit were empty.No harm was done except that the feds spent money on a useless item.Not exactly a (b)(6) golden hammer problem, but still the other test y'all sent was fine and so am i.

• Brand Name: COVID-19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH MANUFACTURING INC.
• MDR Report Key: 16445196
• MDR Text Key: 310331444
• Report Number: MW5115211
• 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: 02/21/2023

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: 02/13/2023
• Device Catalogue Number: ICO-3000
• Device Lot Number: (10): 221CO20214
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2023
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 169 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White