BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 6170953 · Received December 13, 2016

    Report

    Report Number
    2936999-2016-01060
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 18, 2016
    Report Date
    November 25, 2016
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION (ID) AS WELL AS ADDITIONAL INFORMATION ASSOCIATED WITH THE COMPLAINT HAVE BEEN REQUESTED AND IS EITHER UNKNOWN, WILL NOT BE MADE AVAILABLE TO MEDTRONIC, OR WILL BE PROVIDED AND UPDATED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT TRACHEOSTOMY TUBE HAD A CUFF LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819765 SHILEY CANULA DE TRAQUEOSTOMIA FEN 8 JOH COVIDIEN 8FEN 15C0149JZX

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention