BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 20981667 · Received December 19, 2024

    Report

    Report Number
    0002024674-2024-00938
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    December 4, 2024
    Report Date
    December 19, 2024
    Manufacturer
    QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    QKP
    PMA / PMN Number
    EUA210269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: A REVIEW OF THE PACKAGE INSERT (PI) WAS CONDUCTED FOR CLARITY OF INSTRUCTIONS. NO ISSUES WERE FOUND. THE CUSTOMER'S REPORTED PROBLEM WAS RELATED TO A DEVIATION FROM THE INSTRUCTIONS CALLED OUT IN THE PI. ROOT CAUSE: CUSTOMER PROCEDURAL ERROR. SOURCE: PHONE.

    Description of Event or Problem · 0

    REPORTS TEST STRIP WAS INSERTED INTO NOSE. DRY NOSE REPORTED PRIOR TO TESTING AND BLEEDING NOTED AFTER OCCURRENCE. CUSTOMER MENTIONED IRRITATION IN THE NOSE. ADVISED TO FLUSH THE AREA WITH WATER AND CONTACT POISON CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2364288 QUICKVUE AT-HOME OTC COVID-19 TEST QUICKVUE AT-HOME OTC COVID-19 TEST QKP QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown