BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7631648 · Received June 22, 2018

    Report

    Report Number
    2210968-2018-73711
    Event Type
    Injury
    Date Received
    June 22, 2018
    Report Date
    May 31, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. CITATION: JSLS (2010)14:103¿105; DOI: 10.4293/108680810X12674612014860. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: LAPAROSCOPIC HERNIA REPAIR: A TWO-PORT TECHNIQUE AUTHORS: K. THEODOROPOULOU, MD, D. LETHABY, MBBS, BMEDSCI (HONS), J. HILL, MBBS, S. GUPTA, MBBS, BSC (HONS), H. BRADPIECE, FRCS CITATION: JSLS (2010)14:103¿105; DOI: 10.4293/108680810X12674612014860. THE PURPOSE OF THIS STUDY WAS TO DOCUMENT THE 2-PORT TECHNIQUE AND DEMONSTRATE THAT IT IS FEASIBLE, EFFICIENT AND SAFE. BETWEEN JAN2005 AND MAR2007, 40 PATIENTS (N=18 MALE AND N=22 FEMALE; MEAN AGE OF 55.7 YEARS [RANGED 38 TO 78 YEARS]) WITH VENTRAL HERNIAS OR INCISIONAL HERNIAS UNDERWENT LAPAROSCOPIC REPAIR WITH A 2-PORT TECHNIQUE. IN THE PROCEDURE, CREATION OF PNEUOMOPERITONEUM WAS ACHIEVED USING VERESS NEEDLE IN THE LEFT UPPER QUADRANT. SCISSORS¿ TIP OR HARMONIC SCALPEL WERE USED FOR DISSECTION OR ADHESIOLYSIS. THE PARIETAL SURFACE OF THE MESH IS STITCHED WITH ONE CENTRAL PROLENE SUTURE FOR SMALLER MESH (MESH<65 CM2) AND 4 PERIPHERAL SUTURES (NORTH, SOUTH, EAST, WEST) FOR LARGER MESH (MESH>65 CM2). HELICAL FASTENERS ARE USED TO ATTACH THE PERIPHERY OF THE MESH TO THE ABDOMINAL WALL AT INTERVALS OF 1CM. POSTOPERATIVELY, ONE PATIENT DEVELOPED A SEROMA THAT NEEDED ASPIRATION, AND ONE PATIENT DEVELOPED A WOUND INFECTION WHICH WAS TREATED SUCCESSFULLY WITH ANTIBIOTICS. THE CAUSE OF ENTEROTOMY WAS NOT CLEAR, BUT THE AUTHORS BELIEVED THAT IT WAS VERESS NEEDLE INSERTION ¿RELATED. THE MESH USED IN THE PROCEDURE WERE NOT KNOWN TO CAUSE ADHESIONS. ACCORDING TO THE AUTHORS, THE PERSISTENT ABDOMINAL PAIN IN 8 PATIENTS WAS FROM THE SPECIFIC HELICAL FASTENERS. THERE WAS ONE RECURRENCE AT 4 MONTHS POSTOPERATIVELY THAT OCCURRED AT THE PERIPHERY OF THE MESH WHICH WAS THOUGHT THAT THERE WAS SOME WEAKNESS AT THE ABDOMINAL WALL THAT WAS NOT SUFFICIENTLY COVERED BY THE MESH, LEADING TO RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474268 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention