BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 15002959 · Received July 13, 2022

    Report

    Report Number
    1221359-2022-03582
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Date of Event
    June 24, 2022
    Report Date
    July 13, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TECHNICAL SERVICE PROVIDED THE SAFETY DATA SHEET TO THE CUSTOMER AND NO FURTHER ACTION IS REQUIRED. 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 EXPOSING HIS EYES TO THE EXTRACTION REAGENT OF THE BINAXNOW COVID-19 ANTIGEN SELF TEST AFTER MISTAKENLY USING THE EXTRACTION REAGENT AS EYE DROPS. THE CONSUMER REPORTED EXPERIENCING DISCOMFORT AND BURNING SENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772209 BINAXNOW COVID-19 ANTIGEN SELF-TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other