BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELEMED

    MDR report key: 999613 · Received February 13, 2008

    Report

    Report Number
    MW5005468
    Event Type
    Malfunction
    Date Received
    February 13, 2008
    Date of Event
    June 28, 2007
    Report Date
    July 10, 2007
    Manufacturer
    TELEMED SYSTEMS, INC.
    Product Code
    BTG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TELEMED CYTOLOGY BRUSH BROKE AT HANDLE DURING TIME OF BRONCHOSCOPY PROCEDURE, AS BRUSH WAS INSIDE OF PT VIA SCOPE. ITEM SAFELY RETRIEVED FROM PT (BRONCHOSCOPE) - NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELEMED BROCHIAL CYTOLOGY BRUSH BTG TELEMED SYSTEMS, INC. REF 3104 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other