BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 2833699 · Received November 12, 2012

    Report

    Report Number
    2936999-2012-00588
    Event Type
    Injury
    Date Received
    November 12, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 16, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION NOT YET AVAILABLE. PENDING RECEIPT OF SAMPLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CALLER REPORTS DURING INSTALLATION OF THE TUBE THE CUFF DID NOT MAINTAIN THE PRESSURE, WHICH LED TO A DESATURATION OF THE PATIENT. THE CALLER CONFIRMED THAT EXTUBATION AND RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY LOW PRESSURE CUFFED TRACH TUBE JOH COVIDIEN, FORMERLY TYCOHEALTHCARE 110700188X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention