BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 3082599 · Received April 23, 2013

    Report

    Report Number
    2936999-2013-00310
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE CALLER, REPRESENTATIVE OF SURGERY DEPARTMENT, REPORTED THAT THE TUBE LEAKED DURING PRETESTING EFFORTS. THE CALLER SUSPECTED THE TUBE WAS FOUND IN THE CUFF BUT COULD NOT CONFIRM. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173512 SHILEY FENESTRATED LOW PRESSURE CUFFED TR JOH COVIDIEN 0911001172

    Patients

    Seq Age Sex Outcome Treatment
    1