BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 TEST

    MDR report key: 14945571 · Received July 6, 2022

    Report

    Report Number
    MW5110699
    Event Type
    Injury
    Date Received
    July 6, 2022
    Date of Event
    June 23, 2022
    Report Date
    July 4, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WHILE PERFORMING THE BINAXNOW COVID TEST, WHICH I HAD DONE PREVIOUSLY WITH ANOTHER PRODUCT WITHOUT DIFFICULTY, THE END OF THE TESTING STICK CAME OFF DEEP IN MY NOSE. I HAD TO GO TO THE EMERGENCY ROOM TO HAVE THIS REMOVED. ALSO, THE KIT CAME WITH 2 SETS OF DIRECTIONS IN SPANISH, NONE IN ENGLISH. SOME INSTRUCTIONS WERE FOUND ONLINE YET KEPT REFERRING TO THE INFORMATION INCLUDED WITH THE KIT. LOT#:192468 REF: 195-160, EXP 06-01-2023. DATE OF USE: (B)(6) 2022. SUSPECTED COVID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086107 BINAXNOW COVID-19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 192468

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention FUROSEMIDE| METOPROLOL | MULTIVITAMIN| POTASSIUM| TOPIRAMATE | VITAMIN D| WARFARIN