BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTTON TIP WOOD APPLICATOR

    MDR report key: 4381399 · Received December 30, 2014

    Report

    Report Number
    1417592-2014-00127
    Event Type
    Injury
    Date Received
    December 30, 2014
    Date of Event
    December 3, 2014
    Report Date
    December 26, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE APPLICATOR BROKE IN HALF WHEN INSERTED INTO A SACRAL ABSCESS TO MEASURE THE UNDERMINING OF THE WOUND. THE WOUND HAD THICK, PURULENT DRAINAGE. THE RETAINED HALF OF THE APPLICATOR WAS RETRIEVED IN A PHYSICIAN OFFICE WITHOUT FURTHER INCIDENT. NO SAMPLE WAS RETURNED FOR EVALUATION AND A ROOT CAUSE HAD NOT BEEN DETERMINED. A CAUTION STATEMENT ON THE LABELING INDICATES THAT THIS DEVICE SHOULD NOT BE USED IN PROCEDURES WHICH MAY REQUIRE EXCESSIVE PRESSURE. WE CANNOT RULE OUT THE POSSIBILITY THAT PRESSURE EXERTED ON THE STICK COULD HAVE BEEN A CAUSE OR CONTRIBUTING FACTOR TO THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    THE WOODEN STICK BROKE AFTER BEING INSERTED INTO A SACRAL WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859594 COTTON TIP WOOD APPLICATOR KXG MEDLINE INDUSTRIES, INC. 507239725

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention