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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/09/2022

Event Type  Injury  

Event Description

Customer feedback : "45-minutes after taking the test my tongue started tingling.A few minutes later my tongue, and lips started swelling.The area directly below my lower lip started swelling and my bottom teeth became numb feeling.I also had a strange taste in my mouth.I do have an auto-immune disease and non-hogdkins follicular b-cell lymphoma.

Manufacturer Narrative

No medical intervention or treatment has been provided; the user/patient stated 'i do have an auto-immune disease and non-hogdkins follicular b-cell lymphoma.' the user/patient mentioned her auto-immune disease made her very sensitive to chemical residual, and she thought chemicals were left on the swabs during the disinfection process at the factory.The customer's son did not have allergies when using it at the same time, which can rule out the risk of bulk products.Lot number: 213co21224 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.

• 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: 15155228
• MDR Text Key: 297137857
• Report Number: 3008573045-2022-00184
• 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: 08/03/2022

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 Model Number: ICO-3000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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