BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX 9.0MM VOCALAID TRACHEOSTOMY TUBE

    MDR report key: 2843800 · Received October 25, 2012

    Report

    Report Number
    2183502-2012-00495
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 23, 2012
    Report Date
    October 24, 2012
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A FOLLOW UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER 2 DAYS IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX 9.0MM VOCALAID TRACHEOSTOMY TUBE TRACHEOSTOMY TUBES CAZ SMITHS MEDICAL MD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK