BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE CUFFED TRACHEOSTOMY T

    MDR report key: 220208 · Received April 21, 1999

    Report

    Report Number
    2029387-1998-00141
    Event Type
    Malfunction
    Date Received
    April 21, 1999
    Date of Event
    September 30, 1998
    Report Date
    October 30, 1998
    Manufacturer
    MALLINCKRODT MEDICAL,INC
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INVOLVED 8 DCT DEVICE WAS RETURNED TO THE MFR ON 11/3/98 FOR DECONTAMINATION, TESTING AND ANALYSIS. DEVICE EVALUATION RESULTS ARE RECORDED ON SECTION H OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE CUFFED TRACHEOSTOMY T Implant TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL,INC 8 DCT M83270000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN