BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS

    MDR report key: 7986555 · Received October 19, 2018

    Report

    Report Number
    1416980-2018-06662
    Event Type
    Injury
    Date Received
    October 19, 2018
    Report Date
    December 4, 2018
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENTS MEETING THE INCLUSION CRITERIA WERE OVER THE AGE OF 18. 2009 AND 2010. (B)(6). MEHRDAD, MARK, M., MEININGER, MICHAEL S. AND LACEY, MARTIN S. ¿VERITAS BOVINE PERICARDIUM FOR IMMEDIATE BREAST RECONSTRUCTION:A XENOGRAFT ALTERNATIVE TO ACELLULAR DERMAL MATRIX PRODUCTS¿. EUR J PLAST SURG, DOI 10.1007/S00238-012-0736-9 (APR-MAY 2012).

    Additional Manufacturer Narrative · 1

    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 OVER A 24-MONTH PERIOD 54 PATIENTS UNDERWENT 93 IMMEDIATE BREAST RECONSTRUCTIVE PROCEDURES FOLLOWING A STANDARDIZED TECHNIQUE WHERE VERITAS AS A PECTORAL EXPANDER WAS USED. FOLLOWING SURGERY WHERE VERITAS MATRIX WAS UTILIZED, SEVEN EVENTS OF SEROMA AND SIX SURGICAL SITE INFECTIONS WERE EXPERIENCED. PROPHYLACTIC INTRAVENOUS ANTIBIOTIC USE AND INTRAOPERATIVE ANTIBIOTIC IRRIGATION WITH BACITRACIN SOLUTION FOR TISSUE EXPANDERS AND IMPLANTS WAS RECORDED FOR ALL PATIENTS. AN UNREPORTED NUMBER OF PATIENT REQUIRED INPATIENT HOSPITALIZATION AND/OR IMPLANT REMOVAL FOR MAJOR INFECTIONS AND AN UNREPORTED NUMBER OF PATIENTS WITH MINOR INFECTIONS REQUIRED OUTPATIENT ORAL ANTIBIOTIC TREATMENT. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOMES WERE NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826810 VERITAS MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R