BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW

    MDR report key: 12638609 · Received October 14, 2021

    Report

    Report Number
    MW5104630
    Event Type
    Injury
    Date Received
    October 14, 2021
    Date of Event
    October 12, 2021
    Report Date
    October 12, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAVE BEEN RECEIVING WEEKLY NASAL SWABS FOR C19 FOR 7 WEEKS NOW. HAD ADVERSE REACTIONS TO THE FIRST 6, WHICH ARE SUMMARIZED IN A SEPARATE REPORT. THIS REPORT IS FOR THE 7TH SWAB, RECEIVED TODAY ((B)(6) 2021). SWAB HAS TYPICALLY BEEN DRY PRIOR TO ADMINISTRATION. SWAB WAS NOTICEABLY DAMP THIS TIME. NOTICED IMMEDIATE NASAL CONGESTION FOLLOWED BY INTENSE SINUS HEADACHES, ITCHING AND BURNING AT THE POINT OF CONTACT, AND NUMBNESS IN THE UPPER NASAL PASSAGE. MUCH MORE UNCOMFORTABLE THAN PREVIOUS ADVERSE REACTIONS TO THE SWAB. PERFORMED BY (B)(6), CLIA # 14D2184926, LOT # 152120. FDA SAFETY REPORTED ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528246 BINAXNOW CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 14D2184926 152120

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR