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 08/21/2022

Event Type  Injury  

Event Description

Customer feedback : the nasal swab smells so much like chemicals it literally made me gag and throw up when i put it in my nose today.I don't think i even got a good sample i could tolerate it long enough.My daughter's nose bled really bad after hers yesterday and she didn't put it far up.There is something not right.No other tests have smelled or reacted this way.Please tell me if there are chemicals in this swab, it literally made me sick.

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: 222co20210 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.Ihealth labs, inc., has not followed up with the site for a second attempt since the initial inquiry posed on july 1, 2022; therefore, there has been no significant information received to date.The user/patient stated did have known allergies via zendesk and phone call.In zendesk, the user/patient stated she has an allergy to morphine, cephalexin.Lot number: 222co20210 sterilized nasal swabs are used.

• 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: 16590205
• MDR Text Key: 311778429
• Report Number: 3008573045-2023-00027
• 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

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/09/2023
• Device Model Number: ICO-3000
• Device Lot Number: 222CO20210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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): Required Intervention; Other
• Patient Age: 50 YR