BEUDAMED
    FDA Adverse Event Other Summary report: N

    COTTON TIP APPLICATOR IN CUSTOM PACK

    MDR report key: 2904656 · Received January 3, 2013

    Report

    Report Number
    1417592-2013-00001
    Event Type
    Other
    Date Received
    January 3, 2013
    Date of Event
    November 30, 2012
    Report Date
    January 3, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    MPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A LAPAROSCOPY PROCEDURE, THE COTTON TIP CAME OFF THE APPLICATOR. THE SURGEON VISUALIZED IT THROUGH THE SCOPE AS IT DESCENDED DOWN THE TUBE AND REMOVED IT WITH THE GRASPER. IT IS NOT KNOWN, HOW THIS APPLICATOR WAS BEING USED AND WHY IT WAS IN THE TUBE IN THE FIRST PLACE. NO FURTHER INTERVENTION WAS REQUIRED AND NO PT INJURY RESULTED. THE SAMPLE WAS RETURNED AND THE ISSUE WAS CONFIRMED. WE HAVE HAD NO OTHER SIMILAR INCIDENTS REPORTED TO US FOR THIS COMPONENT. A ROOT CAUSE HAS NOT BEEN DETERMINED. NO CORRECTIVE ACTION IS BEING TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPY PROCEDURE, THE COTTON TIP CAME OFF THE APPLICATOR. THE SURGEON VISUALIZED IT THROUGH THE SCOPE AS IT DESCENDED DOWN THE TUBE AND REMOVED IT WITH THE GRASPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3729 COTTON TIP APPLICATOR IN CUSTOM PACK MPN MEDLINE INDUSTRIES, INC. 12HB8314

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention