BEUDAMED
    FDA Adverse Event Death Summary report: N

    MALLINCKRODT

    MDR report key: 696217 · Received April 5, 2006

    Report

    Report Number
    2936999-2006-00136
    Event Type
    Death
    Date Received
    April 5, 2006
    Date of Event
    March 16, 2006
    Report Date
    March 22, 2006
    Manufacturer
    JUAREZ HENEQUEN
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS INTUBATED WITH THE DEVICE IN 06 AND AFTER AN UNSPECIFIED AMOUNT OF DAYS THE TUBE DEVELOPED A CUFF LEAK WHILE IN USE ON THE PATIENT. THE CALLER REPORTED THAT THE CLINICIAN ELECTED TO REPLACE THE DEVICE AND IT WAS CLAIMED THAT FOLLOWING THE REPLACEMENT OF THE TUBE THE PATIENT DEVELOPED BILATERAL PNEWUMOTHORAX WHICH REQUIRED CHEST TUBES. THE CALLER REPORTED THAT AFTER AN UNSPECIFIED AMOUNT OF TIME THE PATIENT DEVELOPED BRAIN ANOXIA AND ADULT RESPIRTORY DISTRESS SYNDROME (ARDS). THE CALLER REPORTED THAT ON 03/06 THE TUBE DEVELPOED A LEAK AGAIN. THE CALLER REPORTED THAT THE PATIENT EXPIRED ON 03/06.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT ETT, ENDOTRACHEAL TUBE CBH JUAREZ HENEQUEN UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death