BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY MODIFIED SINGLE CANNULA TRACHEOSTOMY TUBE

    MDR report key: 258445 · Received January 10, 2000

    Report

    Report Number
    2029387-1999-00176
    Event Type
    Malfunction
    Date Received
    January 10, 2000
    Date of Event
    November 12, 1998
    Report Date
    December 31, 1999
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DIFFICULTIES WERE EXPERIENCED MAINTAINING INFLATION THE PROXIMAL CUFF OF ONE (1), SIZE M10 SCT DEVICE.THE DEVICE HAD BEEN IN USE APPROXIMATELY THIRTEEN (13) DAYS WHEN THE PROBLEM WAS DETECTED. THERE WAS ONE (1) PATIENT INVOLVED AND NO REPORTED INJURY. EVALUATION RESULTS OF THE RETURNED PRODUCT REVEALED NO INFLATION INTERGRITY ABNORMALITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY MODIFIED SINGLE CANNULA TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE JOH MALLINCKRODT MEDICAL, INC. M10 SCT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN