MAUDE Adverse Event Report: HEALGEN SCIENTIFIC CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST; COVID RAPID ANTIGEN SELF-TEST

Catalog Number 10973870

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

No investigation will be performed as the cause is known to be user error.The product insert instructs the user to swab their nostrils prior to placing the swab in the buffer tube.No product problem identified.

Event Description

The customer stated that when using the rapidtest antigen test kit, contrary to the instructions for use, he placed the swab in the buffer solution prior to swabbing his nasal cavity, exposing himself to the buffer solution.The customer was instructed to contact the poison control.Per the safety data sheet, in the event of exposure "after skin contact: wash with soap and water and rinse thoroughly." "after skin contact: no irritating effects anticipated." the customer did not state if he did contact poison control or if any harm was caused due to the exposure.Follow up was not possible as the contact information provided by the customer was in error.

• Brand Name: CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST
• Type of Device: COVID RAPID ANTIGEN SELF-TEST
• Manufacturer (Section D): HEALGEN SCIENTIFIC; 3818 fuqua st.; houston TX 77047
• Manufacturer (Section G): ZHEJIANG ORIENT GENE BIOTECH CO. LTD.; #3784, east yangguang avenue; dipu street anji; huzhou, zhejiang 31330 0; CH 313300
• Manufacturer Contact: cindy horton ; 3818 fuqua st.; houston, TX 77047
• MDR Report Key: 18720594
• MDR Text Key: 336622578
• Report Number: 3009238284-2024-00001
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/16/2024

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 Operator: Lay User/Patient
• Device Catalogue Number: 10973870
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Male