BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7449805 · Received April 22, 2018

    Report

    Report Number
    2210968-2018-72237
    Event Type
    Injury
    Date Received
    April 22, 2018
    Report Date
    March 26, 2018
    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: BRITISH JOURNAL OF SURGERY. 2011; 98: 633 639. DOI: 10.1002/BJS.7398. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: RANDOMIZED CLINICAL TRIAL COMPARING POLYPROPYLENE OR POLYDIOXANONE FOR MIDLINE ABDOMINAL WALL CLOSURE¿ AUTHORS: A. BLOEMEN, P. VAN DOOREN, B. F. HUIZINGA, A. G. M. HOOFWIJK CITATION: BRITISH JOURNAL OF SURGERY. 2011; 98: 633 639. DOI: 10.1002/BJS.7398. THIS PROSPECTIVE RANDOMIZED TRIAL COMPARED THE SUTURE MATERIALS FOR CLOSURE OF THE FASCIA AFTER ABDOMINAL SURGERY. THE STUDY HYPOTHESIZE THAT NON-ABSORBABLE SUTURES (PROLENE) WOULD RESULT IN FEWER INCISIONAL HERNIAS THAN SLOWLY ABSORBED SUTURES (PDS), WHILE NOT CAUSING OTHER COMPLICATIONS SUCH AS SUTURE SINUS OR SURGICAL-SITE INFECTION. A TOTAL OF 456 PATIENTS UNDERWENT AN ELECTIVE OR EMERGENCY MIDLINE LAPAROTOMY AND WERE INCLUDED IN THE STUDY. OF WHICH, 223 PATIENTS WERE RANDOMIZED UNDER CLOSURE WITH PROLENE SUTURES AND 233 PATIENTS UNDER CLOSURE WITH PDS SUTURES. THE CLOSURE OF THE FASCIA OF THE ABDOMINAL WALL WAS PERFORMED AFTER SURGERY HAD BEEN COMPLETED USING ONE OF THE TWO SUTURE MATERIALS (PROLENE 1-0 OR PDS 1-0 SUTURES) AS PRESCRIBED BY RANDOMIZATION. THE FASCIA WAS CLOSED IN A SINGLE LAYER WITH WIDE BITES THROUGH THE RECTUS SHEATH (MINIMUM 1 CM FROM THE INCISION EDGE). THE SUTURE LENGTH TO LAPAROTOMY WOUND LENGTH RATIO WAS AT LEAST 4:1. CONTINUOUS SUTURES AND TWO COMPLETE SUTURE LENGTHS WERE USED FOR ALL WOUNDS. IN THE PROLENE SUTURES GROUP, REPORTED COMPLICATIONS INCLUDED INCISIONAL HERNIA (N-45), FASCIAL DEHISCENCE (N-9), SURGICAL SITE INFECTION (N-14), AND SUTURE SINUS (N-3). IN THE PDS SUTURES GROUP, REPORTED COMPLICATIONS INCLUDED INCISIONAL HERNIA (N-58), FASCIAL DEHISCENCE (N-18), SURGICAL SITE INFECTION (N-18), AND SUTURE SINUS (N-5). PATIENTS WITH INCISIONAL HERNIA WERE TREATED WITH EITHER HERNIA CORSET (N-7) OR SURGICAL REPAIR USING DIRECT CLOSURE OR INSERTION OF MESH (N-14).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292512 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention