BEUDAMED
    FDA Adverse Event Injury Summary report: N

    80S06C-IMPRA CARBOFLO STRAIGHT EPTFE GRAFT

    MDR report key: 443621 · Received February 14, 2003

    Report

    Report Number
    2020394-2003-00002
    Event Type
    Injury
    Date Received
    February 14, 2003
    Date of Event
    December 6, 2002
    Report Date
    January 16, 2003
    Manufacturer
    IMPRA, INC. (AZ) BARD PERIPHERAL VASCULAR
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GRAFT IS LEAKING. THE DOCTOR HAS TO CONTINUE TO DRAIN SEROUS FLUID FROM SUBCUTANEOUS TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 80S06C-IMPRA CARBOFLO STRAIGHT EPTFE GRAFT CARBON EPTFE VASCULAR GRAFT DSY IMPRA, INC. (AZ) BARD PERIPHERAL VASCULAR * 381984

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention