BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 2247700 · Received September 8, 2011

    Report

    Report Number
    2183620-2011-00069
    Event Type
    Injury
    Date Received
    September 8, 2011
    Report Date
    August 11, 2011
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. SAME PROBLEM AND REPORTER AS THE FOLLOWING MFR REPORT NUMBERS, BUT SEPARATE EVENTS: 2183620-2011-00067, 2183620-2011-00068, 2183620-2011-00070, 2183620-2011-00071.

    Description of Event or Problem · 1

    A SURGEON WHO HAS USED VERITAS COLLAGEN MATRIX IN BREAST RECONSTRUCTION CASES HAS STARTED EXCHANGING THE TISSUE EXPANDER FOR PERMANENT BREAST IMPLANTS WITHIN THE LAST TWO MONTHS. AFTER INITIAL POSITIVE RESULTS AT THE SECOND STAGE, IN 5 BILATERAL EXCHANGES, THE SURGEON HAS "NOTICED POOR INCORPORATION OF THE EXPANDER WITH SIGNIFICANT INFLAMMATORY PERI-DEVICE SEROMA. THIS HAS CAUSED DEVICE TURNING AND MISPLACEMENT LEADING TO DIFFICULT SECOND STAGE PROCEDURES." IT WAS NOTED THAT THIS SEEMS TO BE PRESENT WITH PTOTIC STRETCHED OUT BREAST SKIN. NO FURTHER PT INFO REGARDING THESE SPECIFIC EVENTS HAVE BEEN PROVIDED TO SYNOVIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERITAS COLLAGEN MATRIX SURGICAL MESH FTM SYNOVIS SURGICAL INNOVATIONS RM-0618 OR RM-1016 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other