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

Model Number ICO-3000

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Pain (1994)

Event Date 07/31/2022

Event Type  Injury  

Manufacturer Narrative

1.Has followed up via phone call and zendesk on (b)(6) 2022, to inquire for additional information.The customer/user replied by providing pictures and additional information.The user/patient provided medical treatment via zendesk; the user/patient stated after the symptoms appeared, he used aleve and allegra for pain relief and respiratory allergies.The user/patient also used zoloft, hydrochlorothiazide, and valtrex for stress disorders, high blood pressure, and to treat herpes virus infections.The user/patient stated didn't have known allergies via zendesk and phone call.In the phone call, the user/patient thought chemicals were left on the swabs during the disinfection process at the factory.2.Lot number: 223co20220 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.3.Lot number: 223co20220 sterilized nasal swabs are used.4.There has been no significant information received to date.This is the first feedback received by this batch of products, and relevant information is continuously collected.

Event Description

Customer feedback: after testing with ihealth covid-19 antigen rapid test, i have severe headaches, red, painful eyes,runny, burning nose.The swab burned during testing.

• 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, airport economic area 30030-8 ; CH 300308
• MDR Report Key: 15375193
• MDR Text Key: 299450579
• Report Number: 3008573045-2022-00196
• 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: Patient Monitoring
• Type of Report: Initial
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/19/2023
• Device Model Number: ICO-3000
• Device Lot Number: 223CO20220
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: MW5111230
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 50 YR