BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 3093758 · Received April 30, 2013

    Report

    Report Number
    2936999-2013-00334
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 10, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PROBLEM IS DUE TO THE CUFF LOSING PRESSURE/ AIR. THE CUSTOMER CONFIRMED THAT DECANNULATION AND RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187291 SHILEY LOW PRESSURE CUFFED TACH TUBE JOH COVIDIEN 12H0486JZX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention