BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALTH AT HOME COVID-19 TEST KIT

    MDR report key: 20523519 · Received October 24, 2024

    Report

    Report Number
    0002024674-2024-00523
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    September 30, 2024
    Report Date
    October 24, 2024
    Manufacturer
    QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    QKP
    PMA / PMN Number
    EUA210269/S4
    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

    CUSTOMER STATES SHE PUT THE SWAB IN THE REAGENT FIRST, THEN IN BOTH NOSTRILS. CUSTOMER STATES SHE INITIALLY FELT A BURNING SENSATION, AND DID A NASAL CLEANSE PRIOR TO CONTACTING THE MANUFACTURER. THE CUSTOMER WAS ADVISED TO CONTACT POISON CONTROL AND WAS DIRECTED TO THE CONTACT INFORMATION IN THE USER INSTRUCTIONS. CUSTOMER THEN STATED SHE "HAD TO GO" AND DISCONNECTED FROM THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2561454 CVS HEALTH AT HOME COVID-19 TEST KIT CVS HEALTH AT HOME COVID-19 TEST KIT QKP QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown