BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETENE MESH PRODUCT

    MDR report key: 16417712 · Received February 22, 2023

    Report

    Report Number
    9615742-2023-00255
    Event Type
    Injury
    Date Received
    February 22, 2023
    Date of Event
    May 17, 2022
    Report Date
    February 22, 2023
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: UNKABSTACK, UNKNOWN ABSORBATACK. TITLE: COMPARISON OF LAPAROSCOPIC LATERAL SUSPENSION AND LAPAROSCOPIC SACROCOLPOPEXY WITH CONCURRENT TOTAL LAPAROSCOPIC HYSTERECTOMY FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE: A RANDOMIZED CONTROLLED CLINICAL TRIAL. SOURCE: INTERNATIONAL UROGYNECOLOGY JOURNAL (2023) 34:231¿238, 10.1007/S00192-022-05267-6 RECEIVED: 24 FEBRUARY 2022 / ACCEPTED: 17 MAY 2022. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN JANUARY 2019 AND JANUARY 2020, A RETROSPECTIVE STUDY COMPARED THE OUTCOMES OF LAPAROSCOPIC LATERAL SUSPENSION WITH TOTAL LAPAROSCOPIC HYSTERECTOMY (LLS-TLH) AND LAPAROSCOPIC SACROCOLPOPEXY WITH TOTAL LAPAROSCOPIC HYSTERECTOMY (LSC-TLH) IN WOMEN WITH APICAL AND ANTERIOR VAGINAL WALL PROLAPSE BETWEEN JANUARY 2019 AND JANUARY 2020. PARIETENE MESH WAS USED IN BOTH PROCEDURES AND SECURED TO THE VAGINAL WALL WITH A COMPETITOR SUTURE. THERE WERE 80 PATIENTS IN THE STUDY WITH 40 IN EACH GROUP. POSTOPERATIVE COMPLICATIONS INCLUDED: RECURRENCE AND MESH EROSION. MESH EXPOSURE OCCURRED IN ONE PATIENT AND REQUIRED REOPERATION TO EXCISE THE MESH. THREE PATIENTS IN THE LLS-TLH REQUIRED REOPERATION FOR RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227556 UNKNOWN PARIETENE MESH PRODUCT MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETENE MESH PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention