BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 2854222 · Received November 29, 2012

    Report

    Report Number
    2936999-2012-00622
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS CURRENTLY IN TRANSIT TO THE MANUFACTURING SITE FOR ANALYSIS.

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT A CUFF LEAK WAS DISCOVERED DURING PATIENT USE. AT THE TIME OF THE INITIAL CALL, THE TUBE WAS NOT REPLACED BECAUSE THE CALLER WAS PENDING A DOCTORS APPOINTMENT FOR REPLACEMENT BUT INDICATED THAT THE CUFF HAD TO BE REINFLATED DAILY FOR CONTINUED USE. ON (B)(6) 2012, THE CUSTOMER CALLED BACK TO INFORM US THAT THE TUBE WAS REPLACED BY THE PHYSICIAN AND WILL BE RETURNING FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY FENESTRATED LOW PRESSURE CUFFED JOH COVIDIEN, FORMERLY TYCO HEALTHCARE 120200078X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention