BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMASHIELD PLAT FINESSE ULTRATHIN KNIT PATCH

    MDR report key: 1325809 · Received February 24, 2009

    Report

    Report Number
    2242352-2009-00002
    Event Type
    Injury
    Date Received
    February 24, 2009
    Date of Event
    December 1, 2007
    Report Date
    January 26, 2009
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE NO PRODUCT IS BEING RETURNED FOR EVALUATION, THE PHYSICIAN'S EXPERIENCE WITH THIS DEVICE CANNOT BE CONFIRMED OR DENIED. FOLLOWING OUR INVESTIGATION, OUR CONCLUSION TO THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE. SINCE THE EXACT DATE THAT THE LEAKAGE BEGAN HAS NOT BE REPORTED. METHOD: THE DEVICE HISTORY RECORDS FOR THE BATCH WERE REVIEWED. RESULTS: ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH OUR STANDARD PROCEDURES. THE DEVICE HISTORY RECORD FOR THIS BATCH SHOWS THAT THE PRODUCT MET ITS SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION - THERE ARE NO SIMILAR INCIDENTS AGAINST THIS BATCH. TREND REVIEW WAS ALSO PERFORMED FOR ALL BATCHES THAT WERE STERILIZED IN THE SAME STERILE LOAD AS THE REPORTED DEVICE, AND DETERMINED THAT THERE WERE NO SIMILAR COMPLAINTS AGAINST ANY OF THOSE BATCHES. THERE IS NO INCREASE IN THE FREQUENCY OR SEVERITY AS INDICATED VIA AN ANTICIPATED OR KNOWN FAILURE MODE BASED UPON RISK DOCUMENTATION AND/OR HISTORICAL TRENDING. NOTE: ITEMS MARKED "NI" ARE NOT ATTAINABLE AT THIS TIME. SHOULD SUCH INFORMATION BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE PHYSICIAN CLAIMS THAT THE HEMASHIELD PATCH WAS IMPLANTED IN 2005 FOR A CAROTID ENDARTECTOMY PROCEDURE. THE DEVICE WAS REMOVED IN 2008, DUE TO MINOR LEAKAGE EXPERIENCED THROUGHOUT THE PREVIOUS YEAR. THE PHYSICIAN REPORTED THAT THE DEVICE WAS SENT OUT FOR CULTURE AND TESTED POSITIVE FOR INFECTION (TYPE OF INFECTION WAS NOT DISCLOSED). THE PHYSICIAN OPTED TO SURGICALLY CLOSE THE CAROTID ARTERY, RATHER THAN IMPLANT ANOTHER DEVICE. THE PHYSICIAN REPORTED THAT THERE WAS NO INJURY TO THE PT DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD PLAT FINESSE ULTRATHIN KNIT PATCH CARDIOVASCULAR FABRIC DXZ MAQUET CARDIOVASCULAR, LLC 019579P 7802111

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention