BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

    MDR report key: 5075394 · Received September 14, 2015

    Report

    Report Number
    1416980-2015-35892
    Event Type
    Injury
    Date Received
    September 14, 2015
    Report Date
    October 14, 2015
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    DXZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PROSPECTIVE RANDOMIZED STUDY WAS DONE BETWEEN SEPTEMBER 2009 AND JANUARY 2012. FROM LITERATURE: STONE, P.A., ABURAHMA, A., HASS, S., PHANG, D., MOUSA, A., MODAK, A., DEARING, D. PROSPECTIVE RANDOMIZED TRIAL ACUSEAL VS VASCU-GUARD PATCHING FOR CAROTID ENDARTERECTOMY J.VASC.SURG. 58(4): 1164-1165. 2013. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE 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 A SUPERFICIAL SURGICAL SITE INFECTION AFTER UNDERGOING A SURGERY IN WHICH VASCU-GUARD WAS USED. THE CAUSE OF THE INFECTION WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT UNDERWENT A CEA (CAROTID ENDARTERECTOMY). ON AN UNREPORTED DATE GREATER THAN 30 DAYS POST CEA, THE PATIENT DEVELOPED A SUPERFICIAL SURGICAL SITE INFECTION (NOT FURTHER SPECIFIED). THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH UNSPECIFIED ORAL ANTIBIOTICS (DOSES AND FREQUENCIES WERE NOT REPORTED). IT WAS REPORTED THAT THE PATIENT DID NOT HAVE ANY FURTHER COMPLICATING FEATURES. NO FURTHER INFORMATION WAS PROVIDED REGARDING SURGICAL TECHNIQUE OR THE PATIENT'S OUTCOME. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604844 PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ SYNOVIS SURGICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention