BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY TRACHEOSOFT TRACHESTOMY TUBE 7.0MM.

    MDR report key: 611299 · Received July 15, 2004

    Report

    Report Number
    8020889-2004-00046
    Event Type
    Malfunction
    Date Received
    July 15, 2004
    Date of Event
    June 15, 2004
    Report Date
    June 15, 2004
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    FLANGE PLASTIC HAS SEPERATED. NO PATIENT HARM OR INJURY. FLANGE SOFT PLASTIC SEPERATING FROM FLANGE HARD PLASTIC. NO PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY TRACHEOSOFT TRACHESTOMY TUBE 7.0MM. EXTENDED LENGTH TRACHEOSTOMY TUBE JOH MALLINCKRODT MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN