BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTEGRAFT BOVINE GRAFT

    MDR report key: 387150 · Received April 4, 2002

    Report

    Report Number
    2247686-2002-00001
    Event Type
    Malfunction
    Date Received
    April 4, 2002
    Date of Event
    February 19, 2002
    Report Date
    April 4, 2002
    Manufacturer
    ARTEGRAFT, INC.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DISTRIBUTOR REP. NOTIFIED ARTEGRAFT, INC. OF THIS EVENT AT DR.'S REQUEST. HOWEVER, INFO PERTAINING TO THIS EVENT WAS NOT OBTAINED UNTIL 03/2002. THE PT HAD A FEMRO-POPLITEAL PROCEDURE AND AFTER TWO WEEKS A DISCOLORATION AT THE SITE OF IMPLANTATION WAS SEEN. THE GRAFT WAS REPLACED IN THAT AREA WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTEGRAFT BOVINE GRAFT VASCULAR GRAFT DSY ARTEGRAFT, INC. * 01K097-005

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention