BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMASHIELD WOVEN DOUBLE VELOUR GRAFT

    MDR report key: 67112 · Received February 5, 1997

    Report

    Report Number
    2242352-1997-00002
    Event Type
    Injury
    Date Received
    February 5, 1997
    Report Date
    January 9, 1997
    Manufacturer
    MEADOX MEDICALS, INC. DIB OF BOSTON SICIENTIFIC
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE NO PRODUCT IS RETURNED FOR EVALUATION, THE INCIDENTS CANNOT BE CONFIRMED OR DENIED. SECTION "F" COMPLETED BY MFR. CODE 86: SINCE THE DEVICE BATCH NUMBER IS UNK, A REVIEW OF THE MFG BATCH RECORDS FOR THE DEVICE IS NOT POSSIBLE.

    Description of Event or Problem · 1

    POST-OPERATIVE BLEEDING FROM GRAFT. THIS IS ALL THE INFO AVAILABLE AT THIS TIME. SHOULD ADD'L INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD WOVEN DOUBLE VELOUR GRAFT Implant SEALED VASCULAR GRAFT DSY MEADOX MEDICALS, INC. DIB OF BOSTON SICIENTIFIC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other