BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETEX PRODUCT

    MDR report key: 24946766 · Received April 21, 2026

    Report

    Report Number
    9615742-2026-00456
    Event Type
    Injury
    Date Received
    April 21, 2026
    Report Date
    April 21, 2026
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT¿S SATISFACTION AT 2 YEARS AFTER GROIN HERNIA REPAIR: ANY DIFFERENCE ACCORDING TO THE TECHNIQUE? B. ROMAIN, J.-F. GILLION, P. ORTEGA-DEBALLON, N. MEYER, AND THE CLUB HERNIE. HERNIA (2018) 22:801¿812. HTTPS://DOI.ORG/10.1007/S10029-018-1796-Y. PUBLISHED ONLINE: 3 JULY 2018 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 CLUB-HERNIE REGISTRY EXTRACTION DATA, THE SAFETY AND PERFORMANCE OF PARIETEX OPTIMIZED MESH WAS ANALYZED IN PATIENTS WHO UNDERWENT INCISIONAL OR VENTRAL HERNIA SURGERY. THERE WERE 1003 HERNIAS TREATED, OF THESE HERNIAS, 505 (50.3%) WERE INCISIONAL HERNIAS AND 498 (49.7%) WERE PRIMARY VENTRAL HERNIAS. COMPLICATIONS INCLUDED: SEROMA, HEMATOMA, INFECTION, MESH MIGRATION, ABSCESS, PERITONITIS, SMALL BOWEL OBSTRUCTION, AND HERNIA RECURRENCE. SEROMA REQUIRED CT-GUIDED ASPIRATION IN ONE PATIENT, HEMATOMA REQUIRED REOPERATION IN ONE PATIENT, MESH INFECTION REQUIRED REOPERATION IN THREE PATIENTS AND HERNIA RECURRENCE REQUIRED REOPERATION IN FIVE PATIENTS. OF THE THREE PATIENTS WITH MESH INFECTION, ONE ALSO EXPERIENCED MESH MIGRATION, AND THE SECOND DEVELOPED PERITONITIS AND ABSCESS. REOPERATION WAS NOT REQUIRED TO TREAT SMALL BOWEL OBSTRUCTION. THERE WERE TWO DEATHS REPORTED THAT WERE UNRELATED TO THE HERNIA PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001137 UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention