MAUDE Adverse Event Report: IHEALTH LABS, INC. COVID ANTIGEN RAPID TEST KIT (SEALED SWAB IN BOX); CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number ICO-3000

Patient Problems Sneezing (2251); Choking (2464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/30/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 i opened up a sealed test kit (covid) antigen covid-19 rapid test.The test kit is manufactured for ihealth labs inc., 120 san lucar ct, sunnyvale, ca 94086.Upon opening the sealed swab test stick to insert in each nostril, i immediately smelled a very strong chemical odor on the sealed swab, after swab inserted, the inside of my nostrils and then caused me to choke, sneeze, gasp for air, drool, watery eyes and unable to breathe or swallow for approx.1 minute or longer.I thought i was going to choke to death because i could not swallow after a minute or so, i was able to swallow, but the incident was so terrifying because of the side effect from the sealed swab.I called companyon (b)(6) 2023, they said my boxes (3) were counterfeit.Refer reports: mw5146297, mw5146298.

• Brand Name: COVID ANTIGEN RAPID TEST KIT (SEALED SWAB IN BOX)
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC.; 880 w. maude ave; sunnyvale CA 94085
• MDR Report Key: 17852632
• MDR Text Key: 324724452
• Report Number: MW5146299
• 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: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/19/2023
• Device Model Number: ICO-3000
• Device Lot Number: (10)221C020820
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CARBOXYMETHYLCELLULOSE EYEDROPS 0.5%.; CHOLECALCIF 10MGG VITAMIN D.; CLOBETASOL PROPIONATE CREAM 0.05%.; IBUPROFEN 800 MG (AS NEEDED). ; LEVOTHYROXINE (SYNTHROID) 75 MCG. ; VIACTIVE 650MG (CALCIUM).; VITAMIN B12.
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White