BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALGREENS AT HOME COVID-19 TEST KIT

    MDR report key: 20823285 · Received December 2, 2024

    Report

    Report Number
    0002024674-2024-00539
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    November 27, 2024
    Report Date
    December 2, 2024
    Manufacturer
    QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    QKP
    UDI-DI
    311917122045
    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 PRODUCT DID NOT FIND ANY UNUSUAL TREND FOR THE REPORTED COMPLAINT CATEGORY. WITHOUT A LOT NUMBER, NO FURTHER INVESTIGATION CAN BE CONDUCTED. ROOT CAUSE: INSUFFICIENT INFORMATION. SOURCE: PHONE.

    Description of Event or Problem · 0

    REPORTS BLOOD ON COLLECTION SWAB AFTER COLLECTION. NO APARENT ADVERSE EVENT. NO ADDTIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338179 WALGREENS AT HOME COVID-19 TEST KIT WALGREENS AT HOME COVID-19 TEST KIT QKP QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS 311917122045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown