BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINITEST RAPID COVID 19 ANTIGEN SELF TEST

    MDR report key: 19712529 · Received July 9, 2024

    Report

    Report Number
    MW5157134
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 9, 2024
    Manufacturer
    HEALGEN SCIENTIFIC LLC
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CALLER STATED THAT SHE PURCHASED THE CLINITEST RAPID COVID-19 ANTIGEN SELF TEST AND FOUND SOME OF THE BUFFER HAS ONLY A DROP OF THE SOLUTION IN THE VIAL. SHE HAS A TOTAL OF FOUR VIALS AND ALL VIALS ARE FAULTY. SHE TRIED CONTACTING THE MANUFACTURER BUT NONE OF THEIR ONLINE CONTACTS IS WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348192 CLINITEST RAPID COVID 19 ANTIGEN SELF TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP HEALGEN SCIENTIFIC LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention