BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLTRION DIATRUST COVID 19 RAPID TEST AND CARESTART COVID 19 RAPID TE

    MDR report key: 14167794 · Received April 20, 2022

    Report

    Report Number
    MW5109205
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    November 8, 2021
    Report Date
    April 19, 2022
    Manufacturer
    CELLTRIONHEALTHCARE CO LTD., 19 ACADEMY-RO 51BEON-GIL YEONSU-GU ICHEON KOREA, REPUBLIC OF (SOUTH)
    Product Code
    QKP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2715596 CELLTRION DIATRUST COVID 19 RAPID TEST AND CARESTART COVID 19 RAPID TE CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP CELLTRIONHEALTHCARE CO LTD., 19 ACADEMY-RO 51BEON-GIL YEONSU-GU ICHEON KOREA, REPUBLIC OF (SOUTH)
    2715597 CELLTRION DIATRUST COVID 19 RAPID TEST AND CARESTART COVID 19 RAPID TE CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACCESS BIO INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Other WAS NOT TAKING MEDICATION AT THE TIME, NONE