BEUDAMED
    FDA Adverse Event Other Summary report: N

    90017966 COTTON TIPPED APPLICATOR

    MDR report key: 2560546 · Received April 27, 2012

    Report

    Report Number
    1282497-2012-00015
    Event Type
    Other
    Date Received
    April 27, 2012
    Report Date
    April 13, 2012
    Manufacturer
    CITMED CORPORATION
    Product Code
    KXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A COTTON TIPPED APPLICATOR. THE CUSTOMER REPORTED THAT THE STICK BROKE WHILE CLEANING HIS TRACHEOSTOMY. THE APPLICATOR BROKE ABOUT 3 INCHES FROM THE HIP. THE PT WAS ABLE TO REMOVE THE BROKEN PIECE WITH HIS FINGERS. THE PT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 90017966 COTTON TIPPED APPLICATOR COTTON APPLICATOR KXG CITMED CORPORATION 8884541400 1033436

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK