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U.S. Department of Health and Human Services

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

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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 Back to Search Results
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.
 
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Brand NameCELLTRION DIATRUST COVID 19 RAPID TEST AND CARESTART COVID 19 RAPID TE
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
CELLTRIONHEALTHCARE CO LTD., 19 ACADEMY-RO 51BEON-GIL YEONSU-GU ICHEON KOREA, REPUBLIC OF (SOUTH)
MDR Report Key14167794
MDR Text Key289869013
Report NumberMW5109205
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received04/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 04/20/2022 Patient Sequence Number: 1
Treatment
WAS NOT TAKING MEDICATION AT THE TIME, NONE
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