BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 2842125 · Received November 13, 2012

    Report

    Report Number
    2183620-2012-00094
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 13, 2012
    Report Date
    October 17, 2012
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVAL. THE DEVICE HISTORY RECORD WAS REVIEWED. ACCORDING TO THE DEVICE HISTORY RECORD, THE DEVICE MET SPECS AT THE TIME OF MANUFACTURE. SAME REPORTER AND EVENT AS THE FOLLOWING MFR REPORT NUMBER: 2183620-2012-00093.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN ABDOMINAL REPAIR SURGERY ON (B)(6) 2012. PT SUFFERED FROM A GUNSHOT WOUND. COMORBIDITIES INCLUDE INTRA ABDOMINAL SPINAL FISTULA AND POSSIBLE ABDOMINAL SEPSIS. TWO 12CMX25CM PIECES OF VERITAS WERE IMPLANTED. UPON RE-OPERATION ON (B)(6) 2012 DUE TO ANOTHER FISTULA, HOLE IN BOWEL, AND WOUND VAC CHANGE, IT WAS NOTED THAT ONE PIECE OF VERITAS HAD COMPLETELY DISSOLVED WHILE THE OTHER PIECE WAS PARTIALLY PRESENT. ALL REMAINING VERITAS PRODUCT WAS REMOVED ON (B)(6) 2012. F/U CARE CONSISTS OF WOUND VAC APPLICATION EVERY OTHER DAY WITH THE USE OF AN ALTERNATE BIOLOGIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERITAS COLLAGEN MATRIX SURGICAL MESH FTM SYNOVIS SURGICAL INNOVATIONS RM-1225 5777951-1490340

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other