BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PTFE VASCULAR GRAFTS SOFT>=6MM

    MDR report key: 643511 · Received October 26, 2005

    Report

    Report Number
    6000072-2005-00052
    Event Type
    Injury
    Date Received
    October 26, 2005
    Date of Event
    September 29, 2005
    Report Date
    September 29, 2005
    Manufacturer
    BOSTON SCIENTIFIC WAYNE
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR CLAIMS THAT THE GRAFT WAS IMPLANTED IN 1/21/2005 (REASON FOR IMPLANT NOT REPORTED). SOME TIME AFTER THE SURGERY (INCIDENT DATE HAS NOT BEEN REPORTED AND HAS BEEN APPROX FOR MDR PURPOSES ONLY), THE GRAFT WAS FOUND TO HAVE BECOME OBSTRUCTED. THE GRAFT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTFE VASCULAR GRAFTS SOFT>=6MM VASCULAR GRAFT DSY BOSTON SCIENTIFIC WAYNE 481056 6598713

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention