BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COTTON TIPPED APPLICATOR, 6 INCH

    MDR report key: 3071154 · Received April 8, 2013

    Report

    Report Number
    1282497-2013-00010
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 19, 2013
    Manufacturer
    CITMED CORPORATION
    Product Code
    KXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A COTTON TIPPED APPLICATOR. THE CUSTOMER REPORTS THAT THE COTTON CAME OFF THE SWAB AND HAD TO BE REMOVED BY THE DOCTOR USING FORCEPS. THE DOCTOR HAD TO OPEN THE WOUND A LITTLE MORE TO GET THE COTTON OUT. NO MEDICATIONS WERE PRESCRIBED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144426 COTTON TIPPED APPLICATOR, 6 INCH COTTON TIPPED APPLICATOR KXG CITMED CORPORATION 8884541400 12030

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other