BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 1002493 · Received February 26, 2008

    Report

    Report Number
    2936999-2008-00100
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 31, 2008
    Manufacturer
    HENEQUEN
    Product Code
    BTO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY RECEIVED INFORMATION THAT SUGGESTED THAT THERE WAS AIR LEAKAGE FROM THE CUFF AFTER TWO DAYS IN PATIENT USE. THE CUSTOMER REPORTED THAT THE PATIENT WAS RE-INTUBATED AND THERE WAS NO HARM TO THE PATIENT. THE CUSTOMER WILL RETURN THE SAMPLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY TRACHEOSTOMY TUBE BTO HENEQUEN 10FEN-S UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention