BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETENE MESH PRODUCT

    MDR report key: 19488125 · Received June 7, 2024

    Report

    Report Number
    9615742-2024-00813
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    July 20, 2023
    Report Date
    June 7, 2024
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ROMAN BANAKHEVYCH, KLAVDIIA AKYMOVA, KATERYNA PARIIENKO, VSEVOLOD NECHAIEV. "PREVENTION OF COMPLICATIONS OF SURGICAL TREATMENT OF STAGE III-IV CYSTOCELE USING LIGHT POLYPROPYLENE MESH." UROLOGIA JOURNAL, 2024, VOL. 91(1) 212¿219, SAGEPUB.COM/JOURNALS-PERMISSIONS, DOI: 10.1177/03915603231193059. PMID: 37606212, JOURNALS.SAGEPUB.COM/HOME/URJ MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A PROSPECTIVE STUDY COMPARED TWO DIFFERENT TYPES OF VAGINAL WALL REPAIR IN THE SURGICAL TREATMENT OF CYSTOCELE BETWEEN (B)(6) 2017 AND (B)(6) 2020. FOR A TOTAL OF 102 PATIENTS, A MACROPOROUS MESH WAS USED. AFTER PLACEMENT OF THE MESH, THE VAGINAL WALL WAS REPAIRED WITH A COMPETITOR SUTURE USING TWO TECHNIQUES. IN THE MAIN GROUP, A TWO-LAYER CLOSURE WAS PERFORMED WITH A COMPETITOR SUTURE. IN THE COMPARISON GROUP, A SINGLE-ROW SUTURE WAS USED TO CLOSE THE VAGINAL WALL. POSTOPERATIVE COMPLICATIONS INCLUDED VAGINAL EROSION, WHICH WAS REPORTED AS A DECUBITUS ULCER, AND PAIN. EROSION WAS TREATED WITH REOPERATIONS. A PARTIAL MESH EXCISION WAS REQUIRED TO TREAT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2126054 UNKNOWN PARIETENE MESH PRODUCT MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETENE MESH PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention