BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIAGLIA BLUE DOLPHIN PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    MDR report key: 2992817 · Received February 27, 2013

    Report

    Report Number
    1820334-2013-00121
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 6, 2013
    Manufacturer
    COOK, INC.
    Product Code
    JOH
    PMA / PMN Number
    K093469
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT ON THE DEVICE WAS NOT PROVIDED SO WE CANNOT DETERMINE IF THE DEVICE FAILURE WAS LABELED IN THE IFU OR NOT. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT EXPIRED DUE TO AN INCIDENT THAT OCCURRED DURING THE PERCUTANEOUS TRACHEOSTOMY. ALTHOUGH REQUESTED MULTIPLE TIMES, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE REPORTER TO HELP THE MANUFACTURER DETERMINE IF THE COOK DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84154 CIAGLIA BLUE DOLPHIN PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY JOH TUBE TRACHEOSTOMY AND TUBE CUFF JOH COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NP Death