BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGRAFT

    MDR report key: 377895 · Received February 18, 2002

    Report

    Report Number
    2183620-2002-00002
    Event Type
    Injury
    Date Received
    February 18, 2002
    Date of Event
    January 17, 2002
    Report Date
    January 18, 2002
    Manufacturer
    BIO-VASCULAR, INC
    Product Code
    LXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2002, PT UNDERWENT SURGERY FOR "TISSUE LOSS". A BIOGRAFT WAS IMPLANTED AND OCCLUDED AT THE TIME OF IMPLANT. PRODUCT WAS THEN EXPLANTED AND REPLACED WITH ANOTHER BIOGRAFT. SURGEON REPORTED LOSS OF OUTFLOW ARTERY. PT'S CURRENT STATUS IS REPORTED AS "GOOD" BY PT'S SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOGRAFT HUMAN UMBILICAL VEIN GRAFT LXA BIO-VASCULAR, INC 407565 2-OC27-1232

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention