BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOCKED SWAB APPLICATOR

    MDR report key: 1556591 · Received December 4, 2009

    Report

    Report Number
    MW5013869
    Event Type
    Malfunction
    Date Received
    December 4, 2009
    Date of Event
    November 2, 2009
    Report Date
    December 4, 2009
    Manufacturer
    COPAN DIAGNOSTICS INCS.
    Product Code
    KCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    APPLICATOR OPENED AND INSERTED INTO THE RIGHT NARE AND ROTATED AS PROCEDURE. FOLLOWING THE 15 SECONDS IN THE NARE, THE APPLICATION WAS REMOVED NOTING THAT THE SWAB WAS NOT ON THE TIP OF THE APPLICATOR. APPLICATOR HAD BROKEN OFF NOT AT THE PERFORATED AREA BUT CLOSER TO THE SWAB LEAVING THE SWAB IN THE NARE UNOBTAINABLE, PATIENT TRANSFERRED TO ED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOCKED SWAB APPLICATOR NASOPHARYNX SWAB KCJ COPAN DIAGNOSTICS INCS. MDD CE0344 519CS01M

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR