BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRAKE-KIT

    MDR report key: 34297 · Received June 24, 1996

    Report

    Report Number
    34297
    Event Type
    Death
    Date Received
    June 24, 1996
    Date of Event
    June 19, 1996
    Report Date
    June 24, 1996
    Manufacturer
    ACKRAD LABORATORIES, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS DISCOVERED WITH THE TRACHEOSTOMY TUBE OUT, OSTENSIBLY RESULTING FROM MALFUNCTION IN TRACH TIE. PT EXPIRED. AGE AT TIME OF EVENT: 6 YRS, 11 MOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAKE-KIT TRACHEOSTOMY TUBE HOLDER CBH ACKRAD LABORATORIES, INC. 43-1862 5320, 5423

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Death