BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCU-GUARD

    MDR report key: 4964600 · Received August 4, 2015

    Report

    Report Number
    1416980-2015-31264
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    June 22, 2015
    Report Date
    September 8, 2015
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    DXZ
    PMA / PMN Number
    K983602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS WAS NOT COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEVELOPED AN INFECTION AFTER UNDERGOING AN UNSPECIFIED NECK SURGERY IN WHICH VASCU-GUARD WAS SURGICALLY IMPLANTED. THE CAUSE OF THE INFECTION WAS UNKNOWN. THE INDICATION FOR THE SURGERY WAS NOT REPORTED. NO FURTHER DETAIL WAS PROVIDED REGARDING THE USE OF THE VASCU-GUARD DURING THE SURGERY. REPORTEDLY, THERE WAS NO ISSUE WITH THE PRODUCT NOTED BEFORE USE. SUBSEQUENTLY, APPROXIMATELY TWO AND ONE HALF WEEKS AFTER THE SURGERY, THE PATIENT DEVELOPED A STAPHYLOCOCCUS INFECTION AT THE SURGICAL SITE. AS A RESULT, THE PATIENT UNDERWENT ANOTHER SURGERY IN WHICH THE NECK WOUND WAS RE-OPENED AND LEFT OPEN WHILE THE PATIENT WAS TREATED FOR SIX WEEKS WITH UNSPECIFIED ANTIBIOTICS (DOSE, FREQUENCY, AND ROUTE NOT REPORTED). FURTHER OUTCOME OF THE INFECTION WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506294 VASCU-GUARD PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ SYNOVIS SURGICAL INNOVATIONS SP15E18-1050978

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention