BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETEX PRODUCT

    MDR report key: 13472384 · Received February 7, 2022

    Report

    Report Number
    9615742-2022-00099
    Event Type
    Injury
    Date Received
    February 7, 2022
    Date of Event
    September 22, 2020
    Report Date
    February 7, 2022
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: LAPAROSCOPIC VENTRAL MESH RECTOPEXY (LVMR)FOR INTERNAL AND EXTERNAL RECTAL PROLAPSE: AN ANALYSIS OF 122 CONSECUTIVE PATIENTS SOURCE: SURGICAL LAPAROSCOPY ENDOSCOPY & PERCUTANEOUS TECHNIQUES: VOLUME 31, NUMBER 4, AUGUST 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY FROM 2013 TO 2019 EVALUATED OUTCOMES OF LAPAROSCOPIC VENTRAL MESH RECTOPEXY (LVMR) IN 122 PATIENTS WITH INTERNAL RECTAL PROLAPSE (IRP) AND EXTERNAL RECTAL PROLAPSE (ERP). MESH WAS USED AND SECURED TO THE RECTUM AND VAGINA WITH SUTURE AND OTHER NON-MEDTRONIC SUTURES. THE MESH WAS FIXED TO THE SACRAL PROMONTORY WITH TACKER AND THE PERITONEUM WAS CLOSED WITH ANOTHER SUTURES OVER THE MESH. COMPLICATIONS INCLUDE 19 TOTAL RECURRENCES OF ERP: 11 MUCOSAL PROLAPSES REQUIRING A HEMORRHOIDOPEXY PROCEDURE AND 8 FULL-THICKNESS PROLAPSES REQUIRING REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497216 UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Unknown Required Intervention