BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALTH AT HOME COVID-19 TEST KIT

    MDR report key: 20698246 · Received November 15, 2024

    Report

    Report Number
    0002024674-2024-00538
    Event Type
    Injury
    Date Received
    November 15, 2024
    Date of Event
    October 18, 2024
    Report Date
    November 15, 2024
    Manufacturer
    QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    QKP
    UDI-DI
    30014613340188
    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: NO ACTION REQUIRED. CUSTOMER FEEDBACK HAS BEEN DOCUMENTED. ROOT CAUSE: INSUFFICIENT INFORMATION SOURCE: ONLINE REVIEW.

    Description of Event or Problem · 0

    CONSUMER CAME IN CONTACT WITH REAGENT SOLUTION AND CONTACTED POISON CONTROL. NO OTHER INFORMATION WAS PROVIDED. CUSTOMER WAS UNABLE TO BE CONTACTED FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334701 CVS HEALTH AT HOME COVID-19 TEST KIT CVS HEALTH AT HOME COVID-19 TEST KIT QKP QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS 30014613340188

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown