BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETEX PRODUCT

    MDR report key: 8605300 · Received May 13, 2019

    Report

    Report Number
    9615742-2019-01685
    Event Type
    Injury
    Date Received
    May 13, 2019
    Date of Event
    January 1, 2019
    Report Date
    May 13, 2019
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE LAPAROSCOPIC MODIFIED KEYHOLE TECHNIQUE WITH COATED POLYESTER MESH FOR TREATMENT OF PARASTOMAL HERNIA: MEASURES FOR IMPROVING THE OUTCOME SOURCE JOURNAL OF LAPAROENDOSCOPIC AND ADVANCED SURGICAL TECHNIQUES, VOLUME 00, 2019 (1-4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED, THE ARTICLE REPORTED EXPERIENCE WITH MODIFICATIONS TO THE LAPAROSCOPIC KEYHOLE TECHNIQUE FOR TREATMENT OF PARASTOMAL HERNIAS. THE DATE WAS COLLECTED FROM ALL PATIENTS WITH SYMPTOMATIC PARASTOMAL HERNIAS WHO UNDERWENT SURGICAL REPAIR. THE PRIMARY ENDPOINT WAS TO EVALUATE THE RECURRENCE RATE AFTER AT LEAST 1 YEAR. NINETY PATIENTS WERE TREATED WITH THE KEYHOLE TECHNIQUE. EIGHTY-EIGHT PATIENTS WERE TREATED WITH MESH. POST-OPERATIVELY, SEROMA WAS REPORTED IN 4 PATIENTS AND ALL WERE TREATED CONSERVATIVELY WITH CLINICAL MONITORING. ONE PATIENT EXPERIENCED RECURRENCE 3 YEARS POST-OPERATIVELY AND THE AUTHOR REPORTED THE PATIENT HAD GAINED 15KG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397746 UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other