BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX

    MDR report key: 24384880 · Received February 18, 2026

    Report

    Report Number
    9615742-2026-00202
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    September 21, 2025
    Report Date
    February 18, 2026
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 RETROSPECTIVE STUDY LOOKED AT THE OUTCOMES OF VENTRALEX ST MESH VS PARIETEX COMPOSITE MESH REPAIR TECHNIQUES TO HELP SURGEONS MAKE INFORMED DECISIONS REGARDING OPTIMAL MANAGEMENT OF PATIENTS WITH INCISION AND UMBILICAL HERNIAS. FROM DECEMBER 2019 TO NOVEMBER 2023, 50 PATIENTS WITH VENTRAL HERNIAS WERE ENROLLED. THE PATIENTS WERE RANDOMIZED TO ONE OR THE OTHER MESH, BUT POSTOPERATIVE COMPLICATIONS WERE GROUPED TOGETHER. COMPLICATIONS INCLUDED 1 HERNIA RECURRENCE, 2 PATIENTS WITH SURGICAL SITE INFECTIONS, 3 PATIENTS WITH SEROMAS AND 1 PATIENT WITH SKIN NECROSIS. TREATMENTS WERE NOT DOCUMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445102 PARIETEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention