BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH LASERTRUBUS 4MM

    MDR report key: 1628974 · Received March 10, 2010

    Report

    Report Number
    9610520-2010-00001
    Event Type
    Malfunction
    Date Received
    March 10, 2010
    Date of Event
    December 18, 2009
    Report Date
    December 18, 2009
    Manufacturer
    TELEFLEX MEDICAL GMBH
    Product Code
    BTR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN RECEIVED FOR INVESTIGATION, BUT THE INVESTIGATION IS NOT COMPLETE AT THE TIME OF THIS REPORT. A FOLLOW UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED AS: A SPLIT WAS FOUND ON THE LENGTH OF THE TUBE AFTER EXTUBATION FOLLOWING A PROCEDURE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH LASERTRUBUS 4MM LASER ET TUBE BTR TELEFLEX MEDICAL GMBH NA 09161

    Patients

    Seq Age Sex Outcome Treatment
    1