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

Catalog Number 11555845

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Swelling/ Edema (4577)

Event Date 12/24/2021

Event Type  Injury  

Manufacturer Narrative

The customer failed to follow the instructions provided with the device.The buffer solution is not intended to come in contact with the patient or user.Per the safety data sheet, "not classified as dangerous according to directive (ec) no.1272/2008." "after skin contact wash with soap and water and rinse thoroughly.".

Event Description

As holders of the emergency use authorization, siemens healthcare diagnostics is submitting this report on behalf of the manufacturer healgen scientific.The customer reported that they mistakenly soaked the swab in the buffer solution prior to inserting it into their nose and experienced a burning sensation in the throat and edema of the eyelids.The customer received decontamination of nose with physiological serum as well as 30mg of solupred at 3pm and 1 tablet of cetirizine in the evening for three days.

• Brand Name: CLINITEST RAPID COVID-19 ANTIGEN TEST
• Type of Device: COVID RAPID ANTIGEN TEST
• Manufacturer (Section D): HEALGEN SCIENTIFIC; 5213 maple st; bellaire TX 77401
• Manufacturer (Section G): ZHEJIANG ORIENT GENE BIOTECH; 629 east yangguang avenue; dipu, zhejiang 31330 0; CH 313300
• Manufacturer Contact: cindy horton ; 5213 maple st; bellaire, TX 77401
• MDR Report Key: 14076510
• MDR Text Key: 289060425
• Report Number: 3009238284-2022-00001
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: EUA210639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 11555845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female