BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREEN RUSCHLITE MAC 3 BLADE, DISPOSABLE

    MDR report key: 4030163 · Received July 31, 2014

    Report

    Report Number
    1044475-2014-00204
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 9, 2014
    Manufacturer
    TELEFLEX
    Product Code
    GCI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IF THE SAMPLE BECOMES AVAILABLE, A F/U REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS. MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED COMPLAINTS.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE LARYNGOSCOPE BLADE HAS BROKEN PIECES OF PLASTIC FLOATING IN PLASTIC WRAPPING BAG. THE ISSUE WAS DETECTED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449006 RUSCH GREEN RUSCHLITE MAC 3 BLADE, DISPOSABLE LARYNGOSCOPE BLADE GCI TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1