BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBOTE COMPOSITE MESH/15 CM X 10 CM

    MDR report key: 6070567 · Received November 1, 2016

    Report

    Report Number
    9615742-2016-00154
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 4, 2016
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OXJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DEVICE EVALUATED BY MFR?, EVALUATION CODES, DATE RECEIVED BY MFR, TYPE OF REPORTS. POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE SYM1510 MESH. THE MESH WAS RETURNED PARTIALLY INTEGRATED WITH HUMAN TISSUE. VISUAL INSPECTION NOTED A 5 CM HOLE PRESENT IN THE CENTER OF THE MESH, AND A SECOND, SMALLER HOLE PRESENT ON THE OPPOSITE OF THE GREEN MARKING. THE WHITE TEXTILE OF THE MESH WAS NOTED TO BE FRAYING AND OVERSTRETCHED AND SUTURE POINTS WERE NOTED CLOSE TO THE GREEN MARKING. DUE TO THE NATURE OF THE RETURNED MESH, NO FUNCTIONAL EVALUATION COULD BE COMPLETED. BASED ON THE SIZE AND SHAPE OF THE HOLES IN THE MESH, AND THE LOCATION OF THE SUTURE POINTS, THE MOST LIKELY ROOT CAUSE OF THE TORN MESH IS OVERSTRETCHING DUE TO EXCESSIVE TENSION. THE PRODUCT IFU WHICH ACCOMPANIES EACH DEVICE STATES THAT ¿IN ORDER TO MAINTAIN THE ELASTICITY AND THE POROSITY OF THE REINFORCEMENT, IT IS RECOMMENDED THAT THE MESH SHOULD NOT BE OVERLY STRETCHED WHEN IT IS BEING PUT IN PLACE. A MODERATE AND EQUAL TENSION SHOULD BE APPLIED IN ALL DIRECTIONS FOR FIXATION IN ORDER TO ACCOUNT FOR WOUND SHRINKAGE DURING THE HEALING PROCESS.¿ A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMS THAT THIS LOT OF PRODUCTS WAS RELEASED MEETING ALL QUALITY SPECIFICATIONS. NO TRENDS FOR THIS FAILURE MODE HAVE BEEN DETECTED. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, ON (B)(6) 2016, THE SURGEON USED A MESH FOR A VENTRAL HERNIA REPAIR. THE MESH WAS FIXED WITH SUTURES, LAST WEEK ON (B)(6) 2016 THE PATIENT RETURNED BECAUSE OF ACUTE UNREPORTABLE HERNIA IN THE SAME LOCATION. THE SURGEON PERFORMED A SURGERY AND FOUND THAT THERE WERE HOLES IN THE CENTER OF THE MESH. THE SURGEON TOOK OUT THE MESH FOR INSPECTION AND REPLACED IT WITH ANOTHER MESH. THERE WASN`T ANY ISSUES WITH THE MESH AT TIME OF IMPLANT. THE LAST KNOWN PATIENT STATUS IS REPORT AS GOOD AND HAS LEFT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720807 SYMBOTE COMPOSITE MESH/15 CM X 10 CM MESH, SURGICAL, NON-ABSORBABLE, LARGE ABDOMINAL WALL DEFECTS OXJ SOFRADIM PRODUCTION SYM1510 PPF0436X

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention