BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOQSWAB

    MDR report key: 7218297 · Received January 25, 2018

    Report

    Report Number
    7218297
    Event Type
    Malfunction
    Date Received
    January 25, 2018
    Date of Event
    December 28, 2017
    Report Date
    January 19, 2018
    Manufacturer
    COPAN DIAGNOSTICS, INC.
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE SWABBING THE PATIENT'S RIGHT NOSTRIL WITH A FLU SWAB USING APPROPRIATE TECHNIQUE, UPON REMOVING THE SWAB FROM THE NOSTRIL, IT WAS NOTICED THAT THE END OF THE SWAB BROKE OFF IN THE PATIENT'S NOSE AND REMAINED IN THE NOSTRIL. PATIENT WAS INSTRUCTED TO BLOW OUT THE NOSE IN AN ATTEMPT TO REMOVE THE SWAB. UPON EXAMINATION, NO FOREIGN BODY WAS NOTED OR ABLE TO BE RETRIEVED. PATIENT WAS SENT TO AN ENT AND THE SWAB WAS RETRIEVED BY THE ENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62320 FLOQSWAB APPLICATOR, ABSORBENT TIPPED, STERILE KXG COPAN DIAGNOSTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other NOT APPLICABLE.