BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY CUFFLESS FENESTRATED

    MDR report key: 2130257 · Received June 13, 2011

    Report

    Report Number
    2936999-2011-00421
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 17, 2011
    Manufacturer
    COVIDIE / FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TUBE WAS DISCARDED AND THEREFORE, UNAVAILABLE FOR FAILURE INVESTIGATION. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. NO CONCLUSIONS CAN BE MADE WITHOUT THE DEVICE. INFO HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE CALLER STATED THAT SHE REC'D A NEW TRACHEOSTOMY TUBE LAST WEEK AND SWITCHED IT OUT HERSELF. SHE STATED THAT IT MUST HAVE A SHARP EDGE ON IT BECAUSE SHE WAS FEELING A PINCHING SENSATION AROUND THE STOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY CUFFLESS FENESTRATED TRACHEOSTOMY TUBE JOH COVIDIE / FORMERLY TYCO HEALTHCARE 1003001344

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention