BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMASHIELD KNITTED DOUBLE VELOUR FABRIC

    MDR report key: 49304 · Received November 14, 1996

    Report

    Report Number
    2242352-1996-00045
    Event Type
    Injury
    Date Received
    November 14, 1996
    Date of Event
    August 14, 1996
    Report Date
    October 17, 1996
    Manufacturer
    MEADOX MEDICALS, INC. DIV BSC
    Product Code
    DXZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FABRIC WAS IMPLANTED FOR A CAROTID ENDARTERECTOMUY PROCEDURE IN A HEPARINIZED PT WITH LOW CARDIAC OUTPUT. AFTERWARDS, THE HEPARIN WAS RECVERSED WITH PROTAMINE. WITHIN 24 HOURS, THE PT SUFFERED A STROKE DUE TO A THROMBOSIS AT THE OPERATIVE SITE. THE PT WAS THEN THROMBECTOMIZED, BUT NO EVIDENT MECHANICAL CAUSE FOR THE THROMBOSIS WAS FOUND. THE FABRIC WAS LEFT IN. AT THIS TIME, THE PT HAD NOT FULLY RECOVERED FROM THE STROKE. THE PT IS NOW BEING CHECKED FOR HEPARIN ALLERGIES. NOTE: CO HAS NOW LEARNED THAT THE PT'S CONDITION IS IMPROVING. IN ADDITION, THE PT HAS TESTED NEGATIVE FOR HEPARIN ALLERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD KNITTED DOUBLE VELOUR FABRIC Implant CARDIOVASCULAR FABRIC DXZ MEADOX MEDICALS, INC. DIV BSC 019523 296025

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other| R