BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOW FLEX

    MDR report key: 15454748 · Received September 19, 2022

    Report

    Report Number
    MW5112115
    Event Type
    Injury
    Date Received
    September 19, 2022
    Date of Event
    September 10, 2022
    Report Date
    September 15, 2022
    Manufacturer
    ACON LABORATORIES, INC
    Product Code
    QKP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I BOUGHT A FLOW FLEX COVID TEST FROM PUBLIX IN (B)(6) I TOOK THE TEST IT CAME OUT NEGATIVE BUT I WOKE UP THE NEXT MORNING WITH A BLISTER IN MY NOSTRIL IT STILL HAS NOT HEALED. I HAVE BEEN WASHING IT OUT WITH WATER I'VE USED PEROXIDE ON A Q-TIP AND PUT TRIPLE ANTIBIOTIC OINTMENT ON IT BUT THE SORE STILL REMAINS IN MY NOSTRIL AND IS VERY PAINFUL. WASN'T SURE IF ANYBODY ELSE HAD THIS PROBLEM SO I FELT I NEEDED TO REPORT IT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125983 FLOW FLEX CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female