BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 2040847 · Received March 24, 2011

    Report

    Report Number
    2936999-2011-00227
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 25, 2011
    Manufacturer
    COVIDIEN / FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK THEREFORE, THE DATE OF MFR CAN NOT BE DETERMINED. WITHOUT THE SAMPLE, THE FAILURE CANNOT BE CONFIRMED OR A ROOT CAUSE DETERMINED. IF A SAMPLE IS RETURNED, A FAILURE INVESTIGATION WILL BE PERFORMED. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. INFO HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE CALLER STATED THAT ON OLDER PT DEVELOPED AN OPEN SORE USING THE 6DCT. SHE EXPLAINED THAT THE BOTTOM OF THE FLANGE APPEARS TO DIG INTO THE PATIENT'S SKIN. THE PT HAS THINNER SKIN AND THEY HAVE USED PADDING AND "XDERM" WITH NO RELIEF. SHE STATED THAT THEY SOLVED THE PROBLEM BY PLACING A 6SCT THAT HAS SMALLER FLANGE AND DOES NOT CAUSE THE SKIN PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN / FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention