BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET

    MDR report key: 881547 · Received July 16, 2007

    Report

    Report Number
    9610520-2007-00001
    Event Type
    Malfunction
    Date Received
    July 16, 2007
    Date of Event
    May 22, 2007
    Report Date
    July 16, 2007
    Manufacturer
    WILLY RUSCH GMBH
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGED INCIDENT OCCURRED IN A FOREIGN COUNTRY AND MEDICAL DEVICE VIGILANCE REPORT SUBMITTED BY MFR, UNDER PRODUCT CATALOG NUMBER 120304. PRODUCT SOLD IN THE USA UNDER CATALOG NUMBER 120381090. RESULTS OF EVALUATION NOT AVAILABLE AT TIME OF THIS REPORT. FOLLOW UP REPORT TO BE FILED AT COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE REPORTER ALLEGES, THAT CONNECTOR AND THE INFLATION LINE WERE SEPARATED. AFTER REMOVAL OF TUBE SHAFT FROM THE TRACHEA THE CONDITION OF PT WAS GOOD AND NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET ULTRA TRACHEOFLEX TRACHEOSTOMY SET BTO WILLY RUSCH GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention