BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILOOP SILICON SLING UNKNOWN PRODUCT

    MDR report key: 7957145 · Received October 11, 2018

    Report

    Report Number
    2210968-2018-76469
    Event Type
    Injury
    Date Received
    October 11, 2018
    Report Date
    September 21, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GCZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    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: ARCH SURG/VOL 146 (NO. 6), JUNE 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: DYNAMIC PARIETAL CLOSURE: INITIAL EXPERIENCE OF AN ORIGINAL PARIETAL CLOSURE PROCEDURE FOR TREATMENT OF ABDOMINAL WOUND DEHISCENCE" AUTHORS: QUENTIN QASSEMYAR, MD, FRANC¸OIS BROWET, MD, MICHELINE ROBBE, MD, PHD, PIERRE VERHAEGHE, MD, PHD AND JEAN-MARC REGIMBEAU, MD, PHD. CITATION: ARCH SURG/VOL 146 (NO. 6), JUNE 2011. THE AIM OF THIS PAPER WAS TO DISCUSS THE AUTHORS¿ DEVELOPED ¿DYNAMIC PARIETAL CLOSURE¿ TECHNIQUE IN WHICH SILICONE LOOP SUTURES WERE USED TO STRENGTHEN A CONVENTIONAL APONEUROTIC CLOSURE. THE PROCEDURE WAS SIMPLE, QUICK, INEXPENSIVE, AND COMPATIBLE WITH DIGESTIVE STOMAS AND COMPLEX PERITONEAL DRAINAGE. IT HAS THE ADVANTAGES BUT NOT THE DISADVANTAGES OF THE USE OF RETENTION SUTURES OR ABDOMINAL WALL PLASTIC SURGERY. FROM JANUARY 2009 TO DECEMBER 2010, THE AUTHORS PERFORMED A PROSPECTIVE STUDY OF 873 CONSECUTIVE PATIENTS WHO UNDERWENT A MIDLINE LAPAROTOMY. DURING THE PROCEDURE, AT THE TIME OF PARIETAL CLOSURE, SUCCESSIVE MASS CLOSURES WERE PERFORMED ALONG THE ENTIRE LENGTH OF THE MEDIAN LAPAROTOMY WITH ELASTIC SILICONE LOOPS (45 CM IN LENGTH AND 2MMIN DIAMETER [ETHILOOP; ETHICON, (B)(4)]). EACH LOOP WAS SCREWED ONTO THE PROXIMAL END OF A NEEDLE (AS IN DRAIN EXTERNALIZATION) AND WAS PLACED TRANSFASCIALLY ACROSS THE WOUND TO OBTAIN A U-SHAPED SUTURE EVERY 4 CM. THE INCISIONS WERE CLOSED BY A CONTINUOUS, APONEUROTIC SUTURE (PDS; ETHICON, SOMERVILLE, NEW JERSEY). THE SKIN WAS CLOSED CONVENTIONALLY. LASTLY, THE DYNAMIC PARIETAL CLOSURE¿S TENSION WAS ADJUSTED, AND COMPRESSES WERE PLACED BETWEEN THE SKIN AND THE LOOPS. THE OVERALL INCIDENCE RATE FOR ABDOMINAL WOUND DEHISCENCE (DIAGNOSED CLINICALLY WITHIN 2 WEEKS OF THE OPERATION) WAS (N=16). THE ETIOLOGY OF ABDOMINAL WOUND DEHISCENCE WAS MECHANICAL IN 12 PATIENTS AND SEPTIC IN 4 PATIENTS. THE ABDOMINAL WOUND DEHISCENCE RECURRENCE RATE WAS 0%. ALL CASES OF ABDOMINAL WOUND DEHISCENCE PERFORMED AN EMERGENCY PROCEDURE TO REDO THE MIDLINE LAPAROTOMY, EXAMINE THE ABDOMINAL CAVITY (TO CHECK FOR INFECTION), AND THEN PERFORM THE DYNAMIC PARIETAL CLOSURE TECHNIQUE. IN CONCLUSION, DYNAMIC PARIETAL CLOSURE IS AN ORIGINAL, EASY, INEXPENSIVE, AND EFFICIENT PROCEDURE. IT MUST BE EVALUATED WITH LARGER NUMBERS OF PATIENTS. IN INDIVIDUALS WITH A VERY HIGH RISK OF ABDOMINAL WOUND DEHISCENCE, THE DYNAMIC PARIETAL CLOSURE TECHNIQUE COULD PERHAPS BE PERFORMED PREVENTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797737 ETHILOOP SILICON SLING UNKNOWN PRODUCT RETAINER, SURGICAL GCZ ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention