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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUMASIS CO., LTD. CELLTRION DIATRUST COVID-19 AG RAPIDTEST IN VITRO DIAGNOSTICS

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HUMASIS CO., LTD. CELLTRION DIATRUST COVID-19 AG RAPIDTEST IN VITRO DIAGNOSTICS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Diarrhea (1811); Pain (1994); Sore Throat (2396)
Event Type  Injury  
Event Description
On mar 11, 2022, the reporter sent an email to celltrion customer center (cs) that he requesting the components of the celltrion diatrust covid-19 ag rapid test, and to contact by phone number, because adverse reactions occurred after testing with a nasal swab. However, he did not describe the type of symtom of adverse reactions. Although celltrion received this case on march 11, 2022, the celltrion responsible person was aware of this incident on may 26, 2022, and celltrion cs delivered follow-up receipt information as follows. The reporter was being tested during 17 weeks for his job, mandated testing by hcp. The hospital that was doing the testing was using the celltrion rapid tests & care start tests. He was tested multiple times per week. Symptoms began in late (b)(6) (testing date: (b)(6) 2021 to (b)(6) 2022) in conjunction with testing and subsided soon after testing was completed. Green stoles, diarrhea, throat issues (soar & tight throat), lower right quadrant pain. Importer comments: celltrion is continuing to follow up on this incident identifying lot numbers and expiration dates with consumer consent as hcp did not provide a record, and other additional information may be available. Lot numbers#: cv1960802, cv1968479, cv1969106, cv1969924, cv1970767, cv1971772, cv1972613, cv1974253, cv1975958, cv1977769, cv19091815, cv19093448, cv19095291, cv19096400, cv19099490, cv19100420, and cv19101237.
 
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Brand NameCELLTRION DIATRUST COVID-19 AG RAPIDTEST
Type of DeviceIN VITRO DIAGNOSTICS
Manufacturer (Section D)
HUMASIS CO., LTD.
88, jeonpa-ro
dongan-gu
anyang-si, gyeonggi-do 14042
KS 14042
MDR Report Key14573156
MDR Text Key293469449
Report Number3008719759-2022-00073
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 Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/11/2022
Event Location Hospital
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

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