BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY PERCUTANEOUS DUAL CANNULA WITH LOW PRESSURE-LOWER PRO

    MDR report key: 232786 · Received May 18, 1999

    Report

    Report Number
    2029387-1999-00007
    Event Type
    Malfunction
    Date Received
    May 18, 1999
    Date of Event
    November 20, 1998
    Report Date
    May 13, 1999
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MFR'S DEVICE EVAL RESULTS ARE RECORDED IN SECTION H OF THIS REPORT.

    Description of Event or Problem · 1

    THIS IS THE MFR'S SECOND FOLLOW-UP REPORT TO PROVIDE ADDITIONAL INFO AND STATUS INVOLVING A PRODUCT ADVISORY REMEDIAL ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY PERCUTANEOUS DUAL CANNULA WITH LOW PRESSURE-LOWER PRO Implant TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 8 PERC M84178000

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention