MAUDE Adverse Event Report: ANDON MEDICAL CO.,LTD IHEALTH; Coronavirus antigen detection test system.

Model Number ICO-3000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Taste Disorder (4422)

Event Date 12/20/2023

Event Type  malfunction  

Event Description

Event details: i am experiencing a burning in my nose and watering eyes after using the swab for the covid 10 antigen rapid test.I noticed it immediately upon insertion of the swab but thought that was normal so continued with the test.I also experienced a chemical taste in my mouth.I am still experiencing these symptoms 2 hours later.

Manufacturer Narrative

The lot number provided was lot # 231co20817, expiration 2024-11-16.Since this product was provided by amazon and there are no reports of non-authentic occurrences of this lot number, there is no indication that the test is not authentic.Since the customer only used one of the two tests, she was able to return the other half of the test kit.Upon inspection, there was no discoloration or indication of tampering of the swab.Check the swab (lot no.20221219) inspection records and sterilization reports, and the results meet the requirements.As of this report, only this abnormal feedback event has been received.

• Brand Name: IHEALTH
• Type of Device: Coronavirus antigen detection test system.
• Manufacturer (Section D): ANDON MEDICAL CO.,LTD; tianjin, airport economic area 30030 8; CH 300308
• Manufacturer (Section G): ANDON MEDICAL CO.,LTD; tianjin, airport economic area 30030 8; CH 300308
• Manufacturer Contact: ren jun ; tianjin, airport economic area 30030-8 ; CH 300308
• MDR Report Key: 18548740
• MDR Text Key: 333543020
• Report Number: 3008573045-2024-00001
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EUA210470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ICO-3000
• Device Lot Number: 231C020817
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR