BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 11398259 · Received March 1, 2021

    Report

    Report Number
    MW5099697
    Event Type
    Injury
    Date Received
    March 1, 2021
    Date of Event
    February 18, 2021
    Report Date
    February 25, 2021
    Manufacturer
    THERMO FISHER SCIENTIFIC, INC. / APPLIED BIOSYSTEMS / LIFE TECHNOLOGIES CORPORATION
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(6) CONTRACTED BY EMPLOYER TO WEEKLY TEST EMPLOYEES FOR COVID-19. ON (B)(6) 2021, THERMO FISHER SCIENTIFIC, TAQPATH COVID-19 COMBO KIT WAS USED TO COLLECT MY THROAT SAMPLE. (SWAB LOT #20200410, COLLECTION TUBE CONTAINED NO LOT NUMBER). CLINICIAN SWAB THROAT VIGOROUSLY RESULTING IN THROAT PAIN - 7 DAYS. AM A CONSULTANT FROM (B)(6), WORKING AT A COMPANY (B)(6). REPORTED INCIDENT VERBALLY TO REPRESENTATIVE OF (B)(6) CLINIC ON (B)(6) 2021 AND INFORMED THEM I WOULD BE NOTIFYING FDA AS THE PACKAGE INSERT FOR THIS DIAGNOSTIC DEVICE STATES TO "GENTLY SWAB". ADDITIONAL PRODUCT INFORMATION SUCH AS SERIAL NUMBER/ UDI NUMBER WAS NOT KNOWN BY THE EMPLOYEES OF (B)(6) CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290403 TAQPATH COVID-19 COMBO KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR THERMO FISHER SCIENTIFIC, INC. / APPLIED BIOSYSTEMS / LIFE TECHNOLOGIES CORPORATION NA 20200410

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other