BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF TEST

    MDR report key: 12810611 · Received November 15, 2021

    Report

    Report Number
    1221359-2021-03469
    Event Type
    Injury
    Date Received
    November 15, 2021
    Report Date
    December 6, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTED DATA AND ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED GETTING REAGENT SOLUTION WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST IN THEIR NOSE. PER THE CONSUMER, THE PATIENT DIPPED THE SWAB INTO THE REAGENT SOLUTION AND THEN INSERTED THE SWAB INTO THEIR NOSTRILS. PER THE CONSUMER, THERE WAS NO PATIENT HARM DUE TO THE OCCURENCE. ADDITIONALLY, THERE WAS NO DELAY OR IMPACT IN TREATMENT DUE TO THE OCCURENCE. THE CONSUMER WAS TOLD TO FLUSH THE AREA OUT WITH WATER IF IRRITATION PERSISTS. ADDITIONALLY, THE CONSUMER WAS GIVEN 1-800-222-1222 TO CONTACT IF IRRITATION PERSISTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711061 BINAXNOW COVID-19 ANTIGEN SELF TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 160357 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other