BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY PEDIATRIC CUFFED

    MDR report key: 2013285 · Received March 8, 2011

    Report

    Report Number
    2936999-2011-00166
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 8, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K945513
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER STATES THAT AFTER 1 DAY OF USE, THEY NOTICED CUFF DID NOT INFLATE PROPERLY. PATIENT WAS REINTUBATED. NO PATIENT HARM REPORTED. PRE-TEST WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY PEDIATRIC CUFFED TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention