BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90017966 COTTON TIPPED APPLICATOR, 6 INCH, TWO PAC

    MDR report key: 6145476 · Received December 5, 2016

    Report

    Report Number
    1282497-2016-00963
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Report Date
    November 22, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A COTTON TIPPED APPLICATOR. THE CUSTOMER REPORTS THAT THE COTTON FELL OFF OF THE STICK INTO THE PATIENTS WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795058 90017966 COTTON TIPPED APPLICATOR, 6 INCH, TWO PAC COTTON TIPPED APPLICATOR KXG COVIDIEN 8884541400 16016

    Patients

    Seq Age Sex Outcome Treatment
    1