BEUDAMED
    FDA Adverse Event Other Summary report: N

    8.0MM CN RAE FLEX

    MDR report key: 145865 · Received January 16, 1998

    Report

    Report Number
    9681384-1998-00004
    Event Type
    Other
    Date Received
    January 16, 1998
    Date of Event
    November 20, 1997
    Report Date
    January 16, 1998
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    "CUFFS WAS LEAKY, USING 5 TUBES 4 HAD BEEN LEAKY, 3 OF THEM AFTER 1 HR RESPIRATION TIME, REINTUBATION WAS ALWAYS NECESSARY (5 TIMES)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8.0MM CN RAE FLEX TRACHEAL TUBE BTR MALLINCKRODT MEDICAL NA MP31680

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other