BEUDAMED
    FDA Adverse Event Death Summary report: N

    DALE TRACHEOSTOMY TUBE HOLDER

    MDR report key: 612570 · Received June 3, 2005

    Report

    Report Number
    1214422-2005-00001
    Event Type
    Death
    Date Received
    June 3, 2005
    Date of Event
    April 1, 2005
    Report Date
    May 25, 2005
    Manufacturer
    DALE MEDICAL PRODUCTS, INC.
    Product Code
    CAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A NEUROLOGICAL DEPARTMENT AT HOSPITAL INFORMED THE DEALER THAT THEY RECEIVED A REPORT OF AN INCIDENT, WHERE A PT ON PURPOSE OPENED THE VELCRO FASTENER TABS OF THE PURPOSE OPENED THE VELCRO FASTENER TABS OF THE DALE TRACHEOSTOMY TUBE HOLDER KEEPS THE TRACHEOSTOMY TUBE IN PLACE. BY THE HOLDER COMING UNDONE THE TUBE DECANNULATED, WHICH LED TO ASPHYXIA AND DEATH. THE REPORT ABENA RECEIVED FROM THE HOSP ALSO STATED THAT THERE HAD OBVIOUSLY BEEN A MEDOCO-LEGAL INSPECTION OF THE BODY AFTER THE INCIDENT AND THE DEPARTMENT WAS GIVEN A STATEMENT TO MEDICAL OFFICES OF HEALTH SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DALE TRACHEOSTOMY TUBE HOLDER TRACHEOSTOMY TUBE HOLDER CAE DALE MEDICAL PRODUCTS, INC. 240 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death