BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 8757988 · Received July 3, 2019

    Report

    Report Number
    2210968-2019-83633
    Event Type
    Injury
    Date Received
    July 3, 2019
    Report Date
    June 11, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: SURG TODAY (2013) 43:381¿385 / DOI 10.1007/S00595-012-0245-2. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: REPAIR OF SMALL AND MEDIUM SIZE VENTRAL HERNIAS WITH A PROCEED VENTRAL PATCH: A SINGLE CENTER RETROSPECTIVE ANALYSIS" AUTHOR/S: PETER AMBE; ANGELA MEYER; LOTHAR KOHLER. CITATION: SURG TODAY (2013) 43:381¿385 / DOI: 10.1007/S00595-012-0245-2. THE PURPOSE OF THIS SINGLE CENTERED RETROSPECTIVE ANALYSIS WAS TO EVALUATE THE EFFECTIVENESS AND SAFETY OF PROCEED VENTRAL PATCH (PVP) IN THE CLOSURE OF VENTRAL HERNIAS. BETWEEN MAY 2009 AND DEC 2010, A TOTAL OF 57 PATIENTS (N=21 FEMALE, N=36 MALES, MEAN AGE 56.7 YEARS) WITH SMALL AND MEDIUM SIZE VENTRAL HERNIAS WERE TREATED WITH PVP. PATCH INSERTION WAS ATRAUMATIC USING EITHER THE FINGERS OR A CLAMP. A FINGER WAS USED TO PALPATE THE PATCH AND EXCLUDE BOWEL INTERPOSITION. TRACTION WAS THEN PLACED ON THE STRAPS TO POSITION THE PATCH TIGHTLY UP AGAINST THE ABDOMINAL WALL, THUS COVERING THE ENTIRE HERNIA. THE STRAPS WERE THEN SUTURED TO THE FASCIA WITH 2-0 PROLENE AND THE OVERLAPPING REST RESECTED. A FASCIA CLOSURE WAS PERFORMED IN CERTAIN CASES WITH 2-0 PROLENE DEPENDING ON THE SURGEON. THIS WAS FOLLOWED BY A SUBCUTICULAR CLOSURE WITH VICRYL AND SKIN CLOSURE WAS DONE WITH CLIPS. POSTOPERATIVE COMPLICATIONS INCLUDED RECURRENCE (N=1) WHEREIN THE PATCH WAS EVENTUALLY REMOVED AND THE PATIENT WAS DEFINITELY TREATED WITH A MESH IN THE SUBLAY POSITION; AND FISTULA (N=1) WHICH REQUIRED A WOUND REVISION WITHOUT PATCH REMOVAL, SINCE THE FISTULA WAS LIMITED TO THE SUBCUTICULAR AREA. VENTRAL HERNIA CLOSURE WITH PVP IS SAFE AND EFFECTIVE. THE RATES OF COMPLICATION AND RECURRENCE ARE COMPARABLE TO THOSE OF THE BARD VENTRALEX HERNIA PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551259 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention