BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMASHIELD KNITTED DOUBLE VELOUR FABRIC

    MDR report key: 57424 · Received December 17, 1996

    Report

    Report Number
    2242352-1996-00076
    Event Type
    Malfunction
    Date Received
    December 17, 1996
    Date of Event
    November 20, 1996
    Report Date
    November 20, 1996
    Manufacturer
    MEADOX MEDICALS, INC, DIV BSC
    Product Code
    DXZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE ACTUAL PRODUCT USED IN THE SURGERY WAS LEFT IN THE PT AND THEREBY NOT AVAILABLE FOR EVAL, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. EVAL OF THE FOUR RETURNED INTACT SAMPLES FROM THE SAME PACKAGE REVEALED THAT THEY WERE ALL WITHIN POROSITY SPECIFICATION. NO PRODUCT ERROR IS FOUND. CODE 86: THE MANUFACTURING BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL- NO SIMILAR COMPLAINTS AGAINST THIS BATCH.

    Description of Event or Problem · 1

    THE FABRIC WAS IMPLANTED FOR A CAROTID PATCH DURING A CAROTID ENDARTERECTOMY PROCEDURE. UPON DECLAMPING, THE PATCH LEAKED APPROX 400 TO 5OOCC OF BLOOD. TO STOP THE BLEEDING, THE DR APPLIED THROMBIN AND GELFOAM, THEN HEPARIN WAS REVERSED WITH PROTAMINE, THE DEXTRAN IV WAS DISCONTINUED AND THE PATCH WAS PACKED. THE BLEEDING STOPPED AND THE PATCH WAS LEFT IN. THE POST-OPERATIVE CONDITION OF THE PT IS OK.

    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 019516 256120

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other