BEUDAMED
    FDA Adverse Event Other Summary report: N

    90017966 COTTON TIPPED APPLICATOR, 6

    MDR report key: 3644479 · Received February 6, 2014

    Report

    Report Number
    1282497-2014-00012
    Event Type
    Other
    Date Received
    February 6, 2014
    Date of Event
    December 13, 2013
    Report Date
    January 31, 2014
    Manufacturer
    CITMED CORPORATION
    Product Code
    KXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A COTTON TIPPED APPLICATOR. THE CUSTOMER REPORTS THAT THE STICK BROKE JUST BELOW THE COTTON TIP WHILE CLEANING THE STOMA AND THE TRACHEA. THE CUSTOMER FURTHER REPORTS THAT THE BROKEN PIECES FELL INTO HER SON'S AIRWAY AND OCCLUDED IT. NINE ONE ONE WAS CALLED INTO HER SON WAS TAKEN BY AMBULANCE TO THE HOSPITAL ER. THE BROKEN PIECE WAS REMOVED AT THE HOSPITAL AND HER SON IS IN GOOD STATUS CURRENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78463 90017966 COTTON TIPPED APPLICATOR, 6 COTTON TIP APPLICATOR KXG CITMED CORPORATION 8884541400 13025

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other