BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 2033441 · Received March 24, 2011

    Report

    Report Number
    2183620-2011-00027
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 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. 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 APPROX 1 YEAR POST PLACEMENT OF A 10X16 VERITAS PATCH FOR RECONSTRUCTION OF AN ABDOMINAL WALL DEFECT, FOLLOWING A TRAM PROCEDURE, THE PT SUFFERED A BULGE AND WAS TAKEN BACK TO THE OPERATING ROOM FOR REPAIR OF A HERNIATION AT THE SITE OF THE DEFECT. UPON OPENING THE ABDOMEN, THE PHYSICIAN NOTED THAT THE SITE OF THE VERITAS IMPLANT LOOKED LIKE SCAR TISSUE. AN ALTERNATIVE SURGICAL MESH WAS USED TO REPAIR THE HERNIA. THE PT IS REPORTED TO BE DOING "FINE."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention