BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN GRAFT 4-7MM, 45 CM

    MDR report key: 3072695 · Received April 17, 2013

    Report

    Report Number
    MW5029856
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    February 27, 2013
    Report Date
    April 9, 2013
    Manufacturer
    GORE
    Product Code
    DSY
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CREATION OF AV FISTULA USING A PROPATEN GORE GRAFT. PT WITH HISTORY OF HEPARIN INDUCED THROMBOCYTOPENIA. PT WAS RE-ANESTHETIZED, WOUND RE-OPENED, AND GRAFT REPLACED WITH NON-HEPARINIZED GRAFT. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166397 GORE PROPATEN GRAFT 4-7MM, 45 CM VASCULAR GRAFT DSY GORE 3971932P005

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention