MAUDE Adverse Event Report: ANDON MEDICAL CO.,LTD IHEALTH; COVID-19 ANTIGEN RAPID TEST

Model Number ICO-3000

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

Patient Problem Taste Disorder (4422)

Event Date 07/07/2022

Event Type  Injury  

Manufacturer Narrative

The user/patient provided medical treatment via zendesk; the user/patient stated after the symptoms appeared, she used benedryl and extra strength tylenol for pain relief and respiratory allergies.Lot number: 222co20123 has not been identified by ihealth labs, inc., as a counterfeit product, so it is safe to conclude that the device/kit received is a valid ihealth labs, inc., manufactured test kit product.There was no evidence to suggest, based on the initial reports that the ihealth antigen test kit was tampered, altered or compromised.The user/patient stated did have known allergies via zendesk and phone call.In zendesk, the user/patient stated has an allergy to cats, dogs, grass, dust, olive trees, and shrimp.Lot number: 222co20123 sterilized nasal swabs are used.

Event Description

Customer feedback : i have used an ihealth lab test and it was negative both times now my nose has been feeling weird after i used this test.It wasn't feeling like that now it is there anything in the test that could have an allergic reaction for some people?.

• Brand Name: IHEALTH
• Type of Device: COVID-19 ANTIGEN RAPID TEST
• 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, ; CH
• MDR Report Key: 16590274
• MDR Text Key: 311778647
• Report Number: 3008573045-2023-00028
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 20856362005894
• UDI-Public: 20856362005894
• 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: 03/22/2023

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: 04/22/2023
• Device Model Number: ICO-3000
• Device Lot Number: 222CO20123
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2023
• Initial Date FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2022
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 50 YR