BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 8479688 · Received April 3, 2019

    Report

    Report Number
    2210968-2019-79989
    Event Type
    Injury
    Date Received
    April 3, 2019
    Report Date
    March 8, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (PROLENE SUTURE, SECURESTRAP) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PROLENE SUTURE, SECURESTRAP) USED IN THIS PROCEDURE? CITATION: HERNIA (2016) 20: 151¿159; DOI 10.1007/S10029-015-1380-7; PUBLISHED ONLINE: 22 APRIL 2015. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE, TITLE: "PREVENTION OF PARASTOMAL HERNIAS WITH 3D FUNNEL MESHES IN INTRAPERITONEAL ONLAY POSITION BY PLACEMENT DURING INITIAL STOMA FORMATION," AUTHORS: G. KOHLER, A. HOFMANN, M. LECHNER, F. MAYER, H. WUNDSAM, K. EMMANUEL, R. H. FORTELNY, CITATION: HERNIA (2016) 20: 151¿159; DOI 10.1007/S10029-015-1380-7; PUBLISHED ONLINE: 22 APRIL 2015. THIS RETROSPECTIVE STUDY AIMED TO EVALUATE THE EFFICACY OF A 3D MESH DEVICE IN TERMS OF PSH PREVENTION AND TO ANALYZE THE RESULTS OF THE INSTITUTIONS INVOLVED IN THIS STUDY. BETWEEN JANUARY 2009 TO AUGUST 2014, 80 PATIENTS (MALE N=47, FEMALE N=33) WITH MEAN AGE OF 71.4 YEARS (RANGE 46-91) UNDERWENT PERMANENT, TERMINAL OSTOMY FORMATION IN IPOM TECHNIQUE WITH AUGMENTATION BY A 3D INVERSELY FUNNEL-SHAPED MESH DEVICE. THE MESH WAS RELOCATED INTRA-ABDOMINALLY. AFTER THE MESH WAS LAPAROSCOPICALLY UNFOLDED WITH ATRAUMATIC GRASPERS, IT WAS SECURED WITH U-SHAPED, ABSORBABLE TACKS (ETHICON, VIENNA, AUSTRIA, SECURE STRAP IN DOUBLE CROWN TECHNIQUE. THE IMPLANT¿S FLAT PARTS TO THE RIGHT OF THE OSTOMY WERE ARMED WITH NONABSORBABLE MONOFILAMENT SUTURES (ETHICON, PROLENE 2.0 UNITED STATES PHARMACOPEIA) AT 2 CM INTERVALS WHICH WERE PASSED TRANSFASCIALLY AND TRANSCUTANEOUSLY THROUGH THE ABDOMINAL WALL AT A DISTANCE OF 4 CM TO THE RIGHT SIDE OF THE MIDLINE INCISION. COMPLICATIONS INCLUDED PARASTOMAL ABSCESS (SUPERFICIAL SUBCUTANEOUS WOUND INFECTION) (N=3) WHICH REQUIRED INCISION AND DRAINAGE OUTSIDE THE STOMA APPLIANCE UNDER GENERAL ANESTHESIA; PARASTOMAL SEROMA NON-INFECTED (N=2) WHICH WAS TREATED WITH NEEDLE ASPIRATION; PARASTOMAL HERNIA (N=3) IN WHICH ONE PATIENT HAD TO UNDERGO ELECTIVE REOPERATION; SURGICAL SITE SEROMA (N=9), SKIN DEHISCENCE (N=4), SURGICAL SITE SUPERFICIAL INFECTION (N=5), SURGICAL SITE DEEP INFECTIONS (N=2) AND BLEEDING/HEMATOMA (N=3). IN CONCLUSION, THE PROPHYLACTICAL IMPLANTATION OF A SPECIALLY SHAPED, 3D MESH IMPLANT IN IPOM TECHNIQUE DURING INITIAL FORMATION OF A TERMINAL ENTEROSTOMY IS SAFE, HIGHLY EFFICIENT AND COMPARATIVELY EASY TO PERFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272207 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention