BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX 6.0MM VOCALAID TRACHEOSTOMY TUBE

    MDR report key: 1872113 · Received October 11, 2010

    Report

    Report Number
    2183502-2010-00448
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 19, 2010
    Report Date
    October 8, 2010
    Manufacturer
    SMITHS MEDICAL INT'L, LTD
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER 1 DAY 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 6.0MM VOCALAID TRACHEOSTOMY TUBE TRACHEOSTOMY TUBES BTO SMITHS MEDICAL INT'L, LTD NA 1641311

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK