BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPAN ESWAB

    MDR report key: 3946605 · Received July 14, 2014

    Report

    Report Number
    3002444944-2014-00001
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 13, 2014
    Manufacturer
    COPAN ITALIA SPA
    Product Code
    JTW
    PMA / PMN Number
    K061301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF DEVICE HISTORY RECORDS: COPAN CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE BEFORE THE RELEASE ON THE MARKET ON THE SWABS OF THE PRODUCT CODE 482C LOT NUMBER FAEI02. NO ANOMALIES HAVE BEEN FOUND: LOT REPORTED IN THE INCIDENT MET MFG SPECS. (B)(4), THIS IS THE FIRST NOTIFICATION RECEIVED FOR THIS SPECIFIC LOT. THE DEVICE WAS NOT RETURNED TO COPAN FOR EVAL. MECHANICAL TEST ON THE RETAINED SAMPLE FROM THE CLAIMED LOT HAS BEEN PERFORMED: ALL THE TESTED SWABS GAVE CONFIRMING RESULTS. WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT. OUR INVESTIGATION COULD NOT CONFIRM ANY MALFUNCTIONS OR DEFECTS IN THE DEVICE LOT ASSOCIATED WITH THIS INCIDENT. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS.

    Description of Event or Problem · 1

    THE EVENT DESCRIPTION PROVIDED INDICATES THAT A PT SPECIMEN (B)(6) HAD A PERTUSSIS TEST DONE AND SWAB BROKE OFF IN HIS NOSE. THEY HAD TO SEND THE PT TO ENT (EAR, NOSE THROAT SPECIALIST) TO EXTRACT THE DEVICE FROM HIS NOSE. IT DID NOT BREAK OFF AT THE DESIGNATED BREAK OFF AREA. IT BROKE OFF CLOSER TO THE TIP. THERE ARE NO ADVERSE EFFECTS ON THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409967 COPAN ESWAB JTW - JTX JTW COPAN ITALIA SPA 482C FAEI02

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention