BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX D.I.C. TRACHEOSTOMY TUBE

    MDR report key: 1990015 · Received February 9, 2011

    Report

    Report Number
    MW5019383
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 9, 2011
    Manufacturer
    SMITHS NEPHEW ASD INC
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PORTEX 8.0MM TRACHEOSTOMY WAS TESTED PRIOR TO INSERTION. AFTER INSERTION, THE TRACHEOSTOMY CUFF RUPTURED. A NEW PORTEX 8.0MM TRACH WAS OBTAINED AND INSERTED WITHOUT FAILURE. NO ADVERSE OUTCOMES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX D.I.C. TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE 8.0MM JOH SMITHS NEPHEW ASD INC 1874445

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other