BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE FENESTRATED LOW

    MDR report key: 1841384 · Received September 15, 2010

    Report

    Report Number
    2936999-2010-01187
    Event Type
    Injury
    Date Received
    September 15, 2010
    Date of Event
    August 14, 2010
    Report Date
    August 19, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE EVENT OCCURRED LAST WEEK ON (B)(6) 2010. THE PT HAD GONE IN FOR A NON-EMERGENT TRACHEOTOMY AND LESS THAN ONE HOUR INTO THE SURGERY, THE CUFF DEFLATED. THE PT WAS DECANNULATED AND RECANNULATED WITH THE SAME TYPE OF TUBE. CUSTOMER ALSO STATED THAT THE TRACH TUBE HAD BEEN DISCARDED SO IT IS UNAVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE FENESTRATED LOW TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 10053000869

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention