BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 11517041 · Received March 18, 2021

    Report

    Report Number
    2210968-2021-02479
    Event Type
    Injury
    Date Received
    March 18, 2021
    Date of Event
    August 1, 2014
    Report Date
    March 2, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA : 03/18/2021. ARTICLE ATTACHED.

    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS, DEMOGRAPHICS REGARDING THE ADDITIONAL EVENTS CITATION: OBES SURG (2014) 24:1136¿1378 O.193. DOI 10.1007/S11695-014-1292-0.

    Description of Event or Problem · 1

    TITLE: HOW TO MANAGE VENTRAL HERNIAS DISCOVERED DURING SLEEVE GASTRECTOMY? THE OBJECTIVE IS TO STUDY THE POST-OPERATIVE COURSE OF NINE PATIENTS WHO UNDERWENT SUTURE/OPEN MESH REPAIR FOR VENTRAL HERNIAS DURING LAPAROSCOPIC SLEEVE GASTRECTOMY. OUT OF 105 LAPAROSCOPIC SLEEVE GASTRECTOMY PERFORMED FOR MORBID OBESITY, NINE PATIENTS HAD VENTRAL HERNIAS OF VARIOUS SIZES. THE HERNIAS WERE REPAIRED BY MONOFILAMENT NON ABSORBABLE (PROLENE) SUTURES IN FOUR CASES AND BY MESH REPAIR USING POLYPROPYLENE SYNTHETIC MESH BY RETRO MUSCULAR (PRO-PERITONEAL) OPEN TECHNIQUE IN FIVE CASES. REPORTED COMPLICATION AFTER REPAIR WITH MONOFILAMENT NON ABSORBABLE (PROLENE) SUTURES INCLUDED INTESTINAL OBSTRUCTION DUE TO SMALL BOWEL INCARCERATION IN HERNIA SAC (N-1) REQUIRING RE-LAPAROSCOPY AND LAPAROSCOPIC MESH REPAIR, AND RECURRENCE DURING 1.5 YEARS OF FOLLOW UP (N-2). AFTER SLEEVE GASTRECTOMY FOR MORBID OBESITY, MESH REPAIR OF ASSOCIATED VENTRAL HERNIAS MAY BE A MORE APPROPRIATE PROCEDURE IF ADEQUATE MESH INFECTION PREVENTION STRATEGY IS FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417630 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention