BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREENSPEC STUBBY HANDLE

    MDR report key: 3955707 · Received June 12, 2014

    Report

    Report Number
    1044475-2014-00173
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    May 30, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RETURNED FOR EVALUATION, HOWEVER, THE INVESTIGATION WAS NOT COMPLETE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE COMPLAINT ALLEGES THAT THE HANDLE GETS VERY HOT ONCE THE BATTERIES ARE INSTALLED AND THE LIGHT IS ENGAGED. THE ALLEGED DEFECT OCCURRED PRIOR TO PT USE DURING FUNCTIONALITY TESTING. THERE WAS NO REPORT OF PT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348025 RUSCH GREENSPEC STUBBY HANDLE LARYNGOSCOPE HANDLE CCW TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1