BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHIRLEY CUFFED TRACHEOSTOMY TUBE

    MDR report key: 54973 · Received December 10, 1996

    Report

    Report Number
    2029387-1996-00160
    Event Type
    Death
    Date Received
    December 10, 1996
    Date of Event
    October 23, 1996
    Report Date
    November 20, 1996
    Manufacturer
    MALLINCKRODT MEDICAL INC
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA RECEIPT OF UF MEDWATCH REPORT 0113-96-0006 THAT INFLATION COULD NOT BE MAINTAINED ON ONE SIZE 8, CUFFED TRACHEOSTOMY TUBE, MODEL TYPE UNK. PT CODED AND SUBSEQUENT MED INTERVENTION WAS UNSUCCESSFUL. PT EXPIRED. PT, DIAGNOSED WITH ABDOMINAL AORTIC ANEURYSM WAS ADMITTED TO FACILITY IN CRITICAL CONDITION ON 10/10/96. PT'S CONDITION DETERIORATED AND ON 10/21/96 A TRACHEOTOMY PROCEDURE WAS PERFORMED WHERE PT WAS INTUBATED WITH A CUFFED TRACHEOSTOMY TUBE. IT IS UNK IF THE DEVICE WAS TESTED PRIOR TO INSERTION BUT THERE WAS NO REPORTED PROBLEMS ASSOCIATED WITH DEVICE PERFORMANCE DURING THE TWO DAYS PRIOR TO THE STATED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHIRLEY CUFFED TRACHEOSTOMY TUBE Implant TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death NASAL GASTRIC TUBE (MODEL/MFG. UNK)| PURITAN BENNITT 7200