BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM SURGICAL MATRIX THICK

    MDR report key: 6331423 · Received February 15, 2017

    Report

    Report Number
    3005920706-2017-00001
    Event Type
    Injury
    Date Received
    February 15, 2017
    Date of Event
    January 16, 2017
    Report Date
    January 16, 2017
    Manufacturer
    ACELL, INC.
    Product Code
    FTM
    PMA / PMN Number
    K041140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS CONDUCTED ON DISCOVERY. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT IDENTIFIED NO SUBSTANTIAL DEVIATION AND SUPPORT THE PRODUCT WAS MANUFACTURED AND DISTRIBUTED IN COMPLIANCE WITH FDA, STATE, LOCAL AND MANUFACTURER OPERATING PROCEDURES. THERE WAS NO REPORT OF DEVICE FAILURE AT THE TIME OF SURGERY. TESTS OF A SISTER GRAFT FROM THE SAME LOT MET SPECIFICATIONS. THIS MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD MALE PATIENT WITH AN EXTENSIVE SURGICAL HISTORY INCLUDING STOMA SITE REVERSAL, WAS TREATED FOR VENTRAL HERNIA WITH AN ACELL DEVICE. SIX WEEKS POST REPAIR, HE HAD DEVELOPED A SUPERFICIAL SEROMA WHICH RUPTURED AND LEFT A TUNNELING WOUND; THE WOUND WAS TESTED FOR INFECTION AND NONE WAS EVIDENCED. THE WOUND SITE WAS TREATED WITH A DIFFERENT ACELL DEVICE AND IS NOW REPORTEDLY COMPLETELY HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114101 MATRISTEM SURGICAL MATRIX THICK MESH, SURGICAL FTM ACELL, INC. PSMT2030 OM6708-805

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention