BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 16030072 · Received December 21, 2022

    Report

    Report Number
    2531491-2022-00015
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    December 12, 2022
    Report Date
    December 21, 2022
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    END USER REPORTED ALLERGIC REACTION WHEN USING THE TEST KIT PURCHASED FROM A MAJOR PHARMACY. THE HEALTH OF THE USER WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630631 FLOWFLEX COVID-19 ANTIGEN HOME TEST ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP QKP ACON LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other