BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOQSWABS

    MDR report key: 12877783 · Received November 24, 2021

    Report

    Report Number
    MW5105578
    Event Type
    Injury
    Date Received
    November 24, 2021
    Date of Event
    November 12, 2021
    Report Date
    November 22, 2021
    Manufacturer
    COPAN ITALIA
    Product Code
    KXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AFTER FLOQSWAB, HAD A REACTION. ELEVATED HEART RATE, DIZZINESS, NAUSEA, DIARRHEA, FLUSHED FACE, BURNING NOSE, JITTERY OVERALL NOT WELL, FEELING SHORTNESS OF BREATH, NOSE VERY CONGESTED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770177 FLOQSWABS APPLICATOR, ABSORBENT TIPPED, STERILE KXG COPAN ITALIA 502CS01 196M20 L. 2111658

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other