BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALTH AT HOME COVID-19 TEST KIT

    MDR report key: 20354547 · Received October 2, 2024

    Report

    Report Number
    0002024674-2024-00522
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    September 3, 2024
    Report Date
    September 3, 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 STATED SHE PUT THE SWAB IN THE SOLUTION FIRST, THEN PUT THE SWAB INTO BOTH NOSTRILS. CUSTOMER INFORMED SHE FLUSHED HER NOSE WITH WATER AND DID NOT HAVE ANY NOTICEABLE IRRITATION. THE CUSTOMER WAS ADVISED TO MONITOR HOW SHE FEELS, WAS DIRECTED TO THE LIST OF HARMFUL INGREDIENTS, WARNINGS AND PRECAUTIONS, AND POISON HELP PHONE NUMBER IN THE USER INSTRUCTIONS. THE CUSTOMER WAS ADVISED TO CONTACT A MEDICAL DOCTOR AS APPROPRIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635881 CVS HEALTH AT HOME COVID-19 TEST KIT CVS HEALTH AT HOME COVID-19 TEST KIT QKP QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS 3765737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown