MAUDE Adverse Event Report: CELLTRIONHEALTHCARE CO LTD., 19 ACADEMY-RO 51BEON-GIL YEONSU-GU ICHEON KOREA, REPUBLIC OF (SOUTH) CELLTRION DIATRUST COVID 19 RAPID TEST AND CARESTART COVID 19 RAPID TE; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Pain (1994); Sore Throat (2396); Unspecified Gastrointestinal Problem (4491)

Event Date 11/08/2021

Event Type  Injury  

Event Description

I was weekly tested via nasal swabs (rapid) and was developing throat discomfort, upper and lower quadrant pain, green stools, diarrhea every monday, tuesday and wednesday.I would usually get tested at the beginning of the week.I had received a combination of 17 nasal rapid tests (once a week) and these are the manufacturers that produced the rapid tests.(b)(4) i have a workman's comp case that is still open because i have been unsuccessful in receiving the components of those 2 manufacturers.I have not received a weekly testing and felt much better after not receiving the covid tests.I received all of the rapid covid tests at (b)(6) urgent care, (b)(6).Job mandated i get weekly tested.

• Brand Name: CELLTRION DIATRUST COVID 19 RAPID TEST AND CARESTART COVID 19 RAPID TE
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): CELLTRIONHEALTHCARE CO LTD., 19 ACADEMY-RO 51BEON-GIL YEONSU-GU ICHEON KOREA, REPUBLIC OF (SOUTH)
• MDR Report Key: 14167794
• MDR Text Key: 289869013
• Report Number: MW5109205
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/19/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: WAS NOT TAKING MEDICATION AT THE TIME, NONE
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White