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 05/09/2022

Event Type  Injury  

Event Description

Customer feedback: "allergic reaction i experienced after using the swab.".

Manufacturer Narrative

Ihealth labs, inc., customer service has reached out to the site via email with several questions posed to the site/user, and has not received any responses to date.Initial report suggests the level and degree of the allergic reaction was not provided.No information to suggest the patient had received any additional treatment or medical intervention as a result of the allergic reaction.There was no information detailing the patient's pre-existing conditions prior to use, and if any, patient is prone to allergic reaction, specifically with the use of ihealth covid-19 antigen test kit(s) and its components.User did not provide specific product information or pictures, we will follow-up with the site to gather additional information relating to this event.

• 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: 14911709
• MDR Text Key: 295247910
• Report Number: 3008573045-2022-00150
• 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: 07/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2022
• 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
• Date Manufacturer Received: 06/30/2022
• 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