BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTTON TIP WOOD APPLICATOR

    MDR report key: 3775802 · Received April 17, 2014

    Report

    Report Number
    1417592-2014-00040
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    March 18, 2014
    Report Date
    April 17, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KXF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED THEY WERE USING THE WOODEN COTTON TIPPED APPLICATORS TO SWAB INSIDE THE RECTUM. THE WOODEN STICK BROKE AND TWEEZERS WERE USED TO REMOVE SPLINTERED PIECES. THERE WAS NO REPORT OF SERIOUS INJURY OR NEED FOR FURTHER INTERVENTION. NO SAMPLES WERE RETURNED FOR EVALUATION. AS STATED ON THE LABELING, THE COTTON TIPPED APPLICATORS WITH WOODEN SHAFTS ARE NOT INTENDED TO BE USED IN PROCEDURES WHICH MAY REQUIRE EXCESSIVE PRESSURE. EXCESSIVE PRESSURE APPLIED TO THE SHAFT DURING USE IS A POTENTIAL ROOT CAUSE FOR THE REPORTED INCIDENT. WE HAVE NO TREND FOR THIS ISSUE AND NO INFORMATION TO SUGGEST A MANUFACTURING DEFECT EXISTED.

    Description of Event or Problem · 1

    THE CLINICIAN WAS SWABBING INSIDE THE RECTUM AND THE STICK BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235899 COTTON TIP WOOD APPLICATOR KXF MEDLINE INDUSTRIES, INC. 506555032

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other