BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIUMPH-VTX

    MDR report key: 1215636 · Received October 20, 2008

    Report

    Report Number
    1056436-2007-00085
    Event Type
    Other
    Date Received
    October 20, 2008
    Date of Event
    February 21, 2007
    Report Date
    October 15, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT, "DURING CASE IT FELL APART", WAS CONFIRMED. HOWEVER, THE CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD REVIEW REVEALED NO MANUFACTURING VARIANCES RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    DURING CASE, IT FELL APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIUMPH-VTX VASCULAR ACCESS PORT LJT ANGIODYNAMICS, INC. NA 28391

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other