BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 20509663 · Received October 22, 2024

    Report

    Report Number
    0002024674-2024-00535
    Event Type
    Injury
    Date Received
    October 22, 2024
    Date of Event
    October 3, 2024
    Report Date
    October 22, 2024
    Manufacturer
    QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    QKP
    UDI-DI
    30014613339724
    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: NO ADVERSE TREND WAS IDENTIFIED FOR THIS LOT NUMBER FOR THE REPORTED ISSUE. ROOT CAUSE: UNABLE TO DETERMINE. SOURCE: PHONE.

    Description of Event or Problem · 0

    REPORTS LIQUID SPLASHED IN EYES WHILE RUNNING TEST. IRRITATION OCCURRED. ADVISED TO SEEK MEDICAL ATTENTION AND CONTACT POISION CONTROL. DIRECTED TO HAZARDOUS INGREDIENTS WHIN THE USER INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789718 QUICKVUE AT-HOME OTC COVID-19 TEST QUICKVUE AT-HOME OTC COVID-19 TEST QKP QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS 30014613339724

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown