BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS

    MDR report key: 5254962 · Received November 30, 2015

    Report

    Report Number
    1416980-2015-42977
    Event Type
    Injury
    Date Received
    November 30, 2015
    Date of Event
    September 9, 2015
    Report Date
    January 18, 2016
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS RETURNED TO THE OPERATING ROOM AND ONLY A PART OF THE VERITAS WAS VISIBLE, MOST OF THE VERITAS WAS INTEGRATED. NO INTERVENTION HAS BEEN DONE TO THE AFFECTED BREAST AND THE CARE PLAN WAS THAT ANOTHER EXPANDER OR ANOTHER MATRIX MAY BE PLACED IN THE FUTURE. IN APPROXIMATELY FOUR MONTHS FOLLOWING THE RECEIPT OF THIS ADDITIONAL INFORMATION, THE SURGEON IS PLANNING TO EXAMINE THE BREAST WHICH HAD GOOD RESULTS AND EVALUATE HOW THE VERITAS IS INTEGRATED WITHIN THAT TISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR LOT NUMBER SP15G20-1063142 (THE LOT NUMBER AS REPORTED BY THE CUSTOMER WAS 20-1063142). THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A POST-OPERATIVE SEROMA AFTER UNDERGOING A MASTECTOMY ON BOTH BREASTS IN WHICH VERITAS WAS USED. A MASTECTOMY AND IMMEDIATE RECONSTRUCTION WAS PERFORMED ON ONE BREAST WITH GOOD RESULTS; HOWEVER THE RECONSTRUCTION WAS DELAYED ON THE CONTRALATERAL BREAST. SUBSEQUENTLY, THE PATIENT DEVELOPED A POST-OPERATIVE SEROMA ON THE RECONSTRUCTED BREAST REQUIRING WOUND DRAINS FOR FOUR WEEKS. IT WAS REPORTED THAT THERE WERE ISSUES WITH THE ORIGINAL MASTECTOMY SCAR AT AN EARLY STAGE AND THE SCAR BEGAN TO WIDEN AT SIX WEEKS. AS A RESULT, EIGHT WEEKS AFTER THE ORIGINAL MASTECTOMY AND RECONSTRUCTION, THE PATIENT WAS TAKEN BACK TO SURGERY AND IT WAS REPORTED THAT THE VERITAS SHEET WAS NOT VISIBLE IN THE BREAST CAVITY. NO FURTHER INFORMATION REGARDING THE PATIENT'S OUTCOME WAS PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786124 VERITAS MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS 20-1063142

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention