BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASCUTEK LIMITED GELSOFT

    MDR report key: 478336 · Received August 5, 2003

    Report

    Report Number
    9612515-2003-00013
    Event Type
    Other
    Date Received
    August 5, 2003
    Date of Event
    May 28, 2003
    Report Date
    August 4, 2003
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CARDIOVASCULAR PROCEDURE, THE SURGEON ATTEMPTED TO CUT A GELSOFT KNITTED VASCULAR PROSTHESIS USING A CAUTERY. THE USE OF THE CAUTERY ON THE GELATIN SEALED KNITTED VASCULAR PROSTHESIS CAUSED FOCAL BURNING AND THE GRAFT TO IGNITE. THERE WAS NO DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCUTEK LIMITED GELSOFT VASCULAR PROSTHESIS DSY VASCUTEK LTD. NA 39482/1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other