BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MESH

    MDR report key: 8852337 · Received August 1, 2019

    Report

    Report Number
    2210968-2019-85016
    Event Type
    Injury
    Date Received
    August 1, 2019
    Report Date
    July 4, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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 REGARDING THE ADDITIONAL EVENTS. CITATION: SURG OBES RELAT DIS 2008; 4:754 ¿758 / DOI:10.1016/J.SOARD.2008.03.246. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: MANAGEMENT OF VENTRAL HERNIAS DURING LAPAROSCOPIC GASTRIC BYPASS. THE PURPOSE OF THIS RETROSPECTIVE, SINGLE-INSTITUTION STUDY WAS TO DEFINE A RATIONAL APPROACH TO VENTRAL HERNIA MANAGEMENT IN THE GASTRIC BYPASS PATIENT. A TOTAL OF 325 PATIENTS UNDERWENT LAPAROSCOPIC GASTRIC BYPASS (LGB): 26 PATIENTS HAD A VENTRAL HERNIA FOUND AT LGB AND OF THESE 26 PATIENTS, 8 PATIENTS HAD THEIR VENTRAL HERNIA REPAIR (VHR) DEFERRED. THE REMAINING 18 PATIENTS (N=8 UNDERWENT PRIMARY VHR AND N=10 UNDERWENT VHR WITH PROCEED MESH). LARGER HERNIAS (MORE THAN 2CM IN DIAMETER) WERE REPAIRED WITH PROCEED MESH AFTER REDUCTION OF THE HERNIA CONTENTS. THE MESH WAS FIXED TO THE ABDOMINAL WALL USING SEVERAL TRANSFASCIAL SUTURES AND TACKS. INTRAOPERATIVE COMPLICATION INCLUDED COMPLETE DISRUPTION OF THE PRIMARY REPAIR (N=2). POSTOPERATIVE COMPLICATION INCLUDED CHRONIC PAIN (N=1) WHICH WAS RELIEVED BY LAPAROSCOPICALLY TRANSECTING A SINGLE ADHESIVE BAND ATTACHED TO ONE OF THE HERNIA TACKS 3 MONTHS AFTER THE INITIAL SURGERY. MESH INFECTION RATES ARE NOT COMMON WHEN PERFORMED CONCOMITANTLY WITH LGB. SYNTHETIC MESH MATERIALS SHOULD BE CONSIDERED IN THE REPERTOIRE OF TECHNIQUES TO REPAIR VENTRAL HERNIAS DURING GASTRIC BYPASS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647230 PROCEED MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention