BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF TEST

    MDR report key: 15008313 · Received July 13, 2022

    Report

    Report Number
    1221359-2022-03585
    Event Type
    Injury
    Date Received
    July 13, 2022
    Date of Event
    July 7, 2022
    Report Date
    July 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TECHNICAL SERVICES INFORMED THE CUSTOMER THE REAGENT SOLUTION IS A COMBINATION OF CHEMICALS AND THAT IT IS HARMFUL. TECHNICAL SERVICES INFORMED THE CUSTOMER THEY SHOULD WASH THEIR EYES UNDER RUNNING WATER FOR 5-10 MINUTES. TECHNICAL SERVICES PROVIDED THE SAFETY DATA SHEET TO THE CUSTOMER. 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 CUSTOMER REPORTED THAT THE REAGENT SOLUTION SPILLED ONTO THEIR LEFT EYE WHEN USING THE BINAXNOW COVID-19 ANTIGEN SELF TEST. TECHNICAL SERVICES CONFIRMED WITH THE CUSTOMER THAT THEY DO NOT HAVE ANY BURNING SENSATION OR IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2284152 BINAXNOW COVID-19 ANTIGEN SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 182608 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other