BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY PEDIATRIC CUFFED LONG

    MDR report key: 2023162 · Received March 15, 2011

    Report

    Report Number
    2936999-2011-00185
    Event Type
    Injury
    Date Received
    March 15, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 17, 2011
    Product Code
    JOH
    PMA / PMN Number
    K955680
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN AND THEREFORE, THE DATE OF MANUFACTURE CAN NOT BE DETERMINED. IF THE SAMPLE IS RETURNED, A FAILURE INVESTIGATION WILL BE PERFORMED. IF SIGNIFICANT INFORMATION IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER FOUR DAYS OF USE, THE TUBE WAS RIPPED AT THE BEGINNING OF THE CANNULA AND THERE WAS A DEFECT AT THE CUFF; AIR LEAKED FROM THE INFLATED CUFF. THE PATIENT REQUIRED A NON-ROUTINE RE-CANNULATION OF THE TRACHEOSTOMY TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY PEDIATRIC CUFFED LONG TRACHEOSTOMY TUBE JOH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention