BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREEN RUSCHLITE DISP MTL MILL, SIZE 3

    MDR report key: 4535415 · Received February 17, 2015

    Report

    Report Number
    1044475-2015-00073
    Event Type
    Malfunction
    Date Received
    February 17, 2015
    Date of Event
    January 28, 2015
    Report Date
    January 28, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED COMPLAINT CANNOT BE CONFIRMED BECAUSE THE DEFECTIVE SAMPLE WAS NEVER RETURNED FOR INVESTIGATION. THEREFORE, THE ROOT CAUSE CANNOT BE ESTABLISHED. THERE ARE NO CORRECTIVE/PREVENTATIVE ACTIONS ASSIGNED AND NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THERE WAS AN EQUIPLITE BLADE INSIDE OF A GRL PACKAGING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113674 RUSCH GREEN RUSCHLITE DISP MTL MILL, SIZE 3 LARYNGOSCOPE BLADE CCW TELEFLEX MEDICAL 1410432

    Patients

    Seq Age Sex Outcome Treatment
    1