BEUDAMED
    FDA Adverse Event Other Summary report: N

    COTTON TIPPED WOODEN APPLICATOR

    MDR report key: 2483437 · Received March 2, 2012

    Report

    Report Number
    1417592-2012-00008
    Event Type
    Other
    Date Received
    March 2, 2012
    Report Date
    February 27, 2012
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE TIP BROKE OFF IN A PATIENT'S WOUND AND HAD TO BE SURGICALLY REMOVED. THERE WAS NO RESPONSE TO REPEATED MESSAGES LEFT ASKING FOR DETAILS PERTAINING TO THE REPORTED INCIDENT. WE DO NOT KNOW HOW THE APPLICATOR WAS BEING USED. DATE OF THE INCIDENT AND CONDITION OF THE PATIENT WAS NOT REPORTED. A CAUTION STATEMENT ON THE LABEL INDICATES THAT COTTON TIPPED APPLICATORS WITH WOOD SHAFTS SHOULD NOT BE USED IN PROCEDURES WHICH MAY REQUIRE EXCESSIVE PRESSURE AS IT COULD LEAD TO DAMAGE TO THE APPLICATOR. IT IS NOT KNOWN IF PRESSURE WAS BEING APPLIED WHEN THE APPLICATOR WAS BEING USED. WE WERE NOT PROVIDED WITH A SAMPLE TO EVALUATE. A ROOT CAUSE HAS NOT BEEN DETERMINED. DUE TO THE REPORTED INCIDENT AND SUBSEQUENT NEED FOR SURGICAL INTERVENTION, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP BROKE OFF IN A PATIENT'S WOUND AND HAD TO BE SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COTTON TIPPED WOODEN APPLICATOR KXG MEDLINE INDUSTRIES, INC. MDS202000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention