BEUDAMED
    FDA Adverse Event Summary report: N

    SIZE 6 DISP CANNULA LOW PRESSURE CUFFED TRACHEOSTOMY TUBE

    MDR report key: 28361 · Received July 7, 1995

    Report

    Report Number
    28361
    Date Received
    July 7, 1995
    Report Date
    July 5, 1995
    Manufacturer
    MALLINCKRODT MEDICAL TPI, INC.
    Product Code
    BTO
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFO REASONABLY SUGGESTED THAT THERE WAS A PROBABILITY THAT A MEDICAL DEVICE MALFUNCTION HAD CAUSED OR COULD HAVE CAUSED SERIOUS ILLNESS OR INJURY TO A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIZE 6 DISP CANNULA LOW PRESSURE CUFFED TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL TPI, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *