BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM SURGICAL MATRIX

    MDR report key: 5464519 · Received February 26, 2016

    Report

    Report Number
    3005920706-2016-00002
    Event Type
    Injury
    Date Received
    February 26, 2016
    Date of Event
    October 8, 2015
    Report Date
    March 30, 2016
    Manufacturer
    ACELL, INC
    Product Code
    FTM
    PMA / PMN Number
    K141084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FOLLOW-UP REPORT FOR ADDITIONAL PATIENT AND LOT NUMBER INFORMATION THAT WAS RECEIVED SUBSEQUENT TO THE INITIAL FILING. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT IDENTIFIED NO SUBSTANTIAL DEVIATION AND DEMONSTRATED THE PRODUCT WAS MANUFACTURED AND DISTRIBUTED IN COMPLIANCE WITH FDA, STATE, LOCAL, AND MANUFACTURER OPERATING PROCEDURES. TESTS OF A RESERVE SAMPLE FROM THE SAME LOT MET SPECIFICATIONS. THIS MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS CONDUCTED ON DISCOVERY. AT THE TIME OF THIS REPORT, ACELL DID NOT RECEIVE LOT NUMBERS FOR THE DEVICES IN QUESTION. HOWEVER, SINCE IT WAS REPORTED THAT THE PROCEDURES WERE PERFORMED IN (B)(6) 2015, BATCH RECORDS FOR ALL POSSIBLE PRODUCTS USED BY THE PHYSICIAN IN (B)(6) 2015 WERE REVIEWED. A REVIEW OF THE MANUFACTURING RECORDS FOR THESE LOTS IDENTIFIED NO SUBSTANTIAL DEVIATIONS AND PURPORT THE PRODUCTS WERE MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE, LOCAL, AND MANUFACTURER OPERATING PROCEDURES. THERE WERE NO REPORTS OF DEVICE FAILURE AT THE TIME OF SURGERY. TESTS OF SISTER GRAFTS FROM THE IDENTIFIED LOTS MET SPECIFICATIONS. THIS MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    PATIENT HAD AN ESOPHAGEAL GASTRECTOMY AND EXPERIENCED AN ANASTOMOTIC LEAK THAT REQUIRED A DRAIN TO BE PLACED IN THE LEFT INTERIOR WALL FOR DRAINAGE OF FLUID.

    Description of Event or Problem · 1

    ACELL RECEIVED A REPORT OF A SERIES OF ANASTOMOTIC LEAKS IN ESOPHAGEAL CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120980 MATRISTEM SURGICAL MATRIX MESH, SURGICAL FTM ACELL, INC PSM0412 SM3728-35

    Patients

    Seq Age Sex Outcome Treatment
    1 Other