BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM SURGICAL MATRIX

    MDR report key: 6158744 · Received December 9, 2016

    Report

    Report Number
    3005920706-2016-00007
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    September 19, 2016
    Report Date
    November 9, 2016
    Manufacturer
    ACELL, INC
    Product Code
    FTM
    PMA / PMN Number
    K141084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 DEMONSTRATED THAT THE PRODUCT WAS MANUFACTURED AND DISTRIBUTED IN COMPLIANCE WITH FDA, STATE, AND LOCAL LAWS, AS WELL AS ALL MANUFACTURER OPERATING PROCEDURES. THERE WAS NO REPORT OF DEVICE FAILURE FROM THE TREATING PHYSICIAN AT THE TIME OF SURGERY. TESTS OF A RETAIN SAMPLE FROM THE SAME LOT MET LOT RELEASE SPECIFICATIONS. THIS MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    PATIENT DEVELOPED A SMALL BOWEL OBSTRUCTION THREE WEEKS AFTER A COLON ANASTOMOSIS PROCEDURE IN WHICH THE SURGEON EMPLOYED AN ACELL DEVICE. THE OBSTRUCTION REQUIRED SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811010 MATRISTEM SURGICAL MATRIX MESH, SURGICAL FTM ACELL, INC PSM0412 SM6209-35

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention