BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 2063709 · Received April 13, 2011

    Report

    Report Number
    2183620-2011-00029
    Event Type
    Injury
    Date Received
    April 13, 2011
    Report Date
    March 15, 2011
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED SIZE VERITAS PATCH WAS IMPLANTED DURING A BREAST RECONSTRUCTION PROCEDURE. NO COMPLICATIONS DURING THE IMPLANT PROCEDURE WERE REPORTED. AT AN UNSPECIFIED TIME FOLLOWING IMPLANT, THE PT DEVELOPED INFLAMMATION, SEROMA, AND PAIN. THE PT WAS TAKEN BACK TO THE OPERATING ROOM AT 3 MONTHS POST-OP, AT WHICH TIME THE VERITAS PATCH WAS EXPLANTED. THE PT'S STATUS IS CURRENTLY UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention