BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOQ SWABS

    MDR report key: 10082270 · Received May 21, 2020

    Report

    Report Number
    MW5094632
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    May 9, 2020
    Report Date
    May 19, 2020
    Manufacturer
    COPAN ITALIA
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COPAN FLOQSWABS, DURING AN ATTEMPT TO COLLECT A CULTURE ON A PATIENT FOR COVID-19, THE TIP OF THE PCR SWAB THAT WAS USED (ABOUT 4.5CM) BROKE OFF AND IT GOT STUCK IN THE NASOPHARYNGEAL CAVITY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541748 FLOQ SWABS APPLICATOR, ABSORBENT TIPPED, NON-STERILE KXF COPAN ITALIA XA5S108B01 1919615

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other