BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMASHIELD WOVEN DOUBLE VELOUR GRAFT

    MDR report key: 84148 · Received April 14, 1997

    Report

    Report Number
    2242352-1997-00035
    Event Type
    Injury
    Date Received
    April 14, 1997
    Date of Event
    February 26, 1997
    Report Date
    March 18, 1997
    Manufacturer
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Product Code
    MAL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE GRAFT WAS IMPLANTED AS A THORACIC AORTIC REPLACEMENT GRAFT DUE TO AN AORTIC ANEURYSM. IMMEDIATELY AFTER THE PT HAD BEEN TRANSFERRED TO ICU, CLEAR FLUID STARTED TO DRAIN FROM A CHEST TUBE. THE DURATION OF THE DRAINAGE WAS TEN DAYS AND PRODUCED 2500CC. THE PT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD WOVEN DOUBLE VELOUR GRAFT Implant SEALED VASCULAR GRAFT MAL MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 175428 236085

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other