BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 1980391 · Received February 3, 2011

    Report

    Report Number
    2183620-2011-00012
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 6, 2011
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED. ACCORDING TO THE DEVICE HISTORY RECORD, THE DEVICE MET SPECIFICATION AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 11 MONTHS POST IMPLANT OF VERITAS 10X16 PATCH FOR SUPPORT OF THE PEDICLE IN THE TRAM BREAST RECONSTRUCTION PROCEDURE, THE PATIENT REPORTED A "BULGE" IN THE IMPLANT AREA. THE PHYSICIAN NOTED THAT THE PATIENT HAS SUFFERED LOSS OF BREAST FLAP SUPPORT. THERE WAS NO REPORT OF SEROMA, INFECTION OR OTHER COMPLICATION REPORTED PRIOR TO IDENTIFICATION OF THE BULGE. THE PATIENT IS EXPECTED TO UNDERGO REPAIR ON (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERITAS COLLAGEN MATRIX SURGICAL MESH FTM SYNOVIS SURGICAL INNOVATIONS RM 1016 5762540-1219781

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other