BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PARIETEX PRODUCT

    MDR report key: 24180555 · Received January 26, 2026

    Report

    Report Number
    9615742-2026-00062
    Event Type
    Malfunction
    Date Received
    January 26, 2026
    Date of Event
    November 24, 2025
    Report Date
    January 26, 2026
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GUAN, L., NIE, Y., LIU, X., MA, Q., YANG, H., CHEN, J. PROSPECTIVE COHORT STUDY OF BIOLOGICAL VERSUS AND SYNTHETIC MESHES FOR LAPAROSCOPIC REPAIR OF HIATAL HERNIA. HERNIA (2026) 30:20. HTTPS://DOI.ORG/10.1007/S10029-025-03491-9. PAGES 1-8 D10 CONCOMITANT PRODUCT: UNKNOWN TACKER (LOT#: UNKNOWN). 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 ANALYZED THE RECURRENCE RATE, COMPLICATIONS, AND CLINICAL OUTCOMES BETWEEN THE USE OF BIOLOGICAL OR SYNTHETIC (PARIETEX COMPOSITE) MESH FOR LAPAROSCOPIC REPAIR OF HIATAL HERNIAS. THERE WERE 174 PATIENTS ENROLLED FROM APRIL 2022 TO FEBRUARY 2024. BOTH MESH TYPES WERE FIXED ON THE DIAPHRAGM WITH ABSORBABLE PROTACKS. POSTOPERATIVE COMPLICATIONS INCLUDED 1 CASE OF MESH-RELATED REACTION, 2 PATIENTS WITH HERNIA RECURRENCE, AND 5 PATIENTS THAT STILL REQUIRED MEDICATION FOR ACID REFLUX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237444 UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female SEE NOTE ON H11