BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM SURGICAL MATRIX PSM

    MDR report key: 5375206 · Received January 18, 2016

    Report

    Report Number
    3005920706-2016-00001
    Event Type
    Injury
    Date Received
    January 18, 2016
    Date of Event
    November 1, 2015
    Report Date
    December 20, 2015
    Manufacturer
    ACELL, INC
    Product Code
    FTM
    PMA / PMN Number
    K141084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 PURPORT 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

    PATIENT UNDERWENT AN ESOPHAGO-GASTRIC END TO END ANASTOMOSIS SURGERY WITH ACELL DEVICE USED AS REINFORCEMENT. PATIENT SUBSEQUENTLY DEVELOPED A STRICTURE AND REQUIRED BALLOON DILATION AND STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33833 MATRISTEM SURGICAL MATRIX PSM MESH, SURGICAL FTM ACELL, INC PSM0615 SM4043-34

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention