BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF TEST

    MDR report key: 13388012 · Received January 28, 2022

    Report

    Report Number
    1221359-2022-00593
    Event Type
    Injury
    Date Received
    January 28, 2022
    Date of Event
    January 1, 2022
    Report Date
    May 10, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    THE SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. ADDITIONAL INFORMATION:G3 AND H6. TECHNICAL SERVICE PROVIDED THE SAFETY DATA SHEET TO THE CUSTOMER AND NO FURTHER ACTION IS REQUIRED. ACCORDING THE THE PACKAGE INSERT IN195150 V 3.0: PRECAUTIONS THE REAGENT SOLUTION CONTAINS A HARMFUL CHEMICAL (SEE TABLE BELOW). IF THE SOLUTION CONTACTS THE SKIN OR EYE, FLUSH WITH COPIOUS AMOUNTS OF WATER. CHEMICAL NAME/CAS: SODIUM AZIDE/26628-22-8 GHS CODE FOR EACH INGREDIENT: ACUTE TOX. 2 (ORAL), H300 ; ACUTE TOX. 1 (DERMAL), H310 CONCENTRATION : 0.0125% 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 WHILE PERFORMING THE BINAXNOW COVID-19 ANTIGEN SELF TEST THE REAGENT SOLUTION GOT ON THE NASAL SWAB AND THE SWAB WAS PUSHED INTO THE NASAL CAVITY. THE DATE THAT THIS EVENT OCCURRED WAS NOT PROVIDED. THE CONSUMER CONTACTED TECHNICAL SERVICES (TS) FOR FURTHER GUIDANCE. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860146 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