BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRORHEOLOGICS FLOCKED SWAB

    MDR report key: 1027706 · Received April 10, 2008

    Report

    Report Number
    MW5006204
    Event Type
    Malfunction
    Date Received
    April 10, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 28, 2008
    Manufacturer
    COPAN ITALIA
    Product Code
    LIO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SWAB WAS USED TO COLLECT A NASOPHARYNGEAL SPECIMEN. AS SWAB WAS REMOVED, IT WAS NOTED THAT THE TIP END OF THE SWAB REMAINED IN PT'S NOSE. PT DESCRIBED A DISCOMFORT OF SOMETHING BEING INITIALLY STUCK IN NOSE AND LATER SAID THAT SHE BELIEVED IT HAD BEEN SWALLOWED. AT NO POINT DID PT APPEAR TO BE IN ACUTE DISTRESS OR DISCOMFORT BEYOND THAT ASSOCIATED WITH A BLOCKED NASAL PASSAGEWAY. THE SWAB TIP COULD NOT BE SEEN IN THE NOSE OR THROAT; IT WAS NOT RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRORHEOLOGICS FLOCKED SWAB SPECIMEN COLLECTION SWAB LIO COPAN ITALIA * E17 1 RTK00

    Patients

    Seq Age Sex Outcome Treatment
    1