BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMASHIELD KNITTED DOUBLE VELOUR FABRIC

    MDR report key: 117534 · Received September 3, 1997

    Report

    Report Number
    2242352-1997-00071
    Event Type
    Injury
    Date Received
    September 3, 1997
    Date of Event
    July 30, 1997
    Report Date
    August 5, 1997
    Manufacturer
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Product Code
    DXZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FABRIC WAS IMPLANTED AS A CAROTID PATCH. AT THE END OF THE PROCEDURE, THE HEPARIN WAS REVERSED WITH PROTAMINE. APPROXIMATELY 1-2 HOURS AFTER SURGERY, THE PT DEVELOPED A STROKE. AND EXPERIENCED UPPER EXTREMITY DISABILITY. THE FABRIC WAS EXPLANTED DURING A SECOND SURGERY AND REPLACED WITH A VEIN PATCH. THROMBOSIS WAS FOUND ON THE EXPLANTED PATCH. THE PT WAS SUBSEQUENTLY PLACED INTO A REHABILITATION PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD KNITTED DOUBLE VELOUR FABRIC Implant CARDIOVASCULAR FABRIC DXZ MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 019508 146366

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization| R| S PHYSICAL THERAPY SUBSEQUENT TO SURGERY DATE UNKN.