BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH LITE SLIM MAC 3 BLADE

    MDR report key: 2110943 · Received April 15, 2011

    Report

    Report Number
    1044475-2011-00039
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 24, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THIS IS THE SECOND OF FOUR EVENTS THAT STATE THE BLADE CRACKED WHILE INTUBATING. ALL PARTS RETRIEVED, NO PATIENT HARM WAS REPORTED. A MEDWATCH REPORT WAS ALSO RECEIVED STATING THESE FOUR EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH LITE SLIM MAC 3 BLADE LARYNGOSCOPE MAC 3 BLADE GEI TELEFLEX MEDICAL NA 1015131

    Patients

    Seq Age Sex Outcome Treatment
    1