BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 14674768 · Received June 13, 2022

    Report

    Report Number
    1221359-2022-02825
    Event Type
    Injury
    Date Received
    June 13, 2022
    Date of Event
    May 19, 2022
    Report Date
    June 13, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED FOR THE INITIAL AND INVESTIGATION COMPLETION. TECHNICAL SERVICES ATTEMPTED TO PROVIDE THE SAFETY DATA SHEET TO THE CUSTOMER, BUT THE CUSTOMER STATED THAT THEY ALREADY RECEIVED A RESOLUTION AND NO LONGER NEED ASSISTANCE. ACCORDING TO THE PACKAGE INSERT IN195150C V.3.0: PRECAUTIONS 20. THE REAGENT SOLUTION CONTAINS A HARMFUL CHEMICAL (SEE TABLE BELOW). IF THE SOLUTION CONTACTS THE SKIN OR EYE, FLUSH WITH COPIOUS AMOUNTS OF WATER. IF IRRITATION PERSISTS, SEEK MEDICAL ADVICE: HTTPS://WWW.POISON.ORG/CONTACT-US OR 1-800-222-1222. BASED ON THE ABOVE SUMMARY THE INVESTIGATION IS DEEMED COMPLETE. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED THAT THE PATIENT HAD ACCIDENTALLY DIPPED THE SWAB INTO THE REAGENT PRIOR TO INSERTING THE SWAB IN THEIR NOSTRIL. CONSUMER REPORTED THAT THEY HAD NO ADVERSE AFFECTS FROM THE REAGENT AFTER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879023 BINAXNOW COVID-19 ANTIGEN SELF-TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 179884 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other