BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOQSWABS

    MDR report key: 4549338 · Received December 17, 2014

    Report

    Report Number
    4549338
    Event Type
    Malfunction
    Date Received
    December 17, 2014
    Date of Event
    December 9, 2014
    Report Date
    December 17, 2014
    Manufacturer
    COPAN DIAGNOSTICS, INC.
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    WHILE OBTAINING A VIRAL FLU SWAB SPECIMEN, THE SNAP OFF PORTION OF THE SWAB WAS RETAINED IN THE LEFT NARE (NOSTRIL) OF THE PATIENT. THE PHYSICIAN (MD) WAS INFORMED. NASAL AND NASOPHARYNGEAL SUCTIONING WAS PERFORMED WITHOUT SUCCESSFUL OBJECT REMOVAL. THE MD USED A FIBEROPTIC SCOPE TO EXAMINE INSIDE THE NARES WITHOUT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829582 FLOQSWABS APPLICATOR, ABSORBENT TIPPED, NON-STERILE KXF COPAN DIAGNOSTICS, INC. * AE3500

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR