BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER LIFESPAN EPTFE GRAFT

    MDR report key: 239421 · Received September 9, 1999

    Report

    Report Number
    6000002-1999-00253
    Event Type
    Injury
    Date Received
    September 9, 1999
    Date of Event
    June 2, 1999
    Report Date
    August 10, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED AS A GRAFT ABANDONED. THE REASON FOR REOPERATION IS UNK; HEMORRHAGE INDICATED IN MEDICAL RECORDS ON 05/14/1999 PER SURGEONS' OFFICE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER LIFESPAN EPTFE GRAFT Implant REINFORCED PTFE VASCULAR GRAFT DSY BAXTER HEALTHCARE CORP. RS47050 9C0495

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention