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

Catalog Number GTIN(01): 20856362005894

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 02/23/2022

Event Type  malfunction  

Event Description

Received 2 boxes of ihealth covid-19 antigen rapid test from the usps delivery program (2 tests per box).Opened the first box and attempted to follow the instructions to complete test, but was unable to remove the "large orange cap" from the solution vial so i could insert the swab.Tried various methods but never succeeded in getting the cap off, so i switched to the other solution vial.This cap was also very difficult to remove, but i did succeed in getting it off and completed the test.Afterwards, i continued to try to remove the orange cap on the first vial but could not get it off.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: 13618756
• MDR Text Key: 286334164
• Report Number: MW5107738
• 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: 02/23/2022

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: 07/21/2022
• Device Catalogue Number: GTIN(01): 20856362005894
• Device Lot Number: 223CO20122
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2022
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White