BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPAN STERILE SWAB APPLICATOR

    MDR report key: 967858 · Received December 18, 2007

    Report

    Report Number
    MW5004734
    Event Type
    Injury
    Date Received
    December 18, 2007
    Date of Event
    December 14, 2007
    Report Date
    December 18, 2007
    Manufacturer
    COPAN ITALIA SPA/NORTH AMERICAN DISTRIBUTOR
    Product Code
    KXF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SWAB TIP BROKE OFF IN PT'S NOSE WHILE SWABBING. TIP THEN WAS LOST, UNTIL RECOVERED IN THE BACK OF THE THROAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COPAN STERILE SWAB APPLICATOR SWAB KXF COPAN ITALIA SPA/NORTH AMERICAN DISTRIBUTOR CE0344 503CS01.US, 3H11 L.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other