BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GRAFT

    MDR report key: 642905 · Received October 21, 2005

    Report

    Report Number
    6000072-2005-00050
    Event Type
    Injury
    Date Received
    October 21, 2005
    Date of Event
    October 10, 2005
    Report Date
    October 14, 2005
    Manufacturer
    BOSTON SCIENTIFIC WAYNE
    Product Code
    DYF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR CLAIMS THAT A PREVIOUSLY IMPLANTED GRAFT (MFR AND TYPE NOT REPORTED) WAS EXPLANTED DUE TO AN INFECTION NOT LINKED TO THE GRAFT. THE EXPLANTED GRAFT WAS REPLACED WITH A HEMASHIELD GRAFT (SEE INC# M08150510/14, MDR REF. # 6000072-2005-00049). THE PT'S POST-OPERATIVE CONDITION WAS OK. THE CLINICAL OUTCOME OF THE CASE WAS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN GRAFT UNKNOWN GRAFT DYF BOSTON SCIENTIFIC WAYNE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other| R