BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARIETEX

    MDR report key: 22291617 · Received June 19, 2025

    Report

    Report Number
    9615742-2025-00744
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    April 6, 2025
    Report Date
    September 11, 2025
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CHIH-YUAN WANG, TI-HSUAN CHIEN, CHIH-YING CHIEN. "THE MENTORING EFFECTS OF LEARNING CURVE OF TOTAL EXTRAPERITONEAL HERNIOPLASTY: THE CUSUM ANALYSIS OF THE PIONEER AND SECOND-GENERATION SURGEON". SURGICAL ENDOSCOPY (2025) 39:3337¿3345. HTTPS://DOI.ORG/10.1007/S0046 4-025-11729-X. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT A PHOTO WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED A MESH SLIGHTLY FOLDED BUT WELL POSITIONED INTO THE ABDOMINAL WALL. IT WAS REPORTED THAT POSTOPERATIVE CHRONIC PAIN OCCURRED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE USE OF PARIETEX¿ HYDROPHILIC 2-DIMENSIONAL MESH, PARIETEX¿ HYDROPHILIC 3-DIMENSIONAL MESH AND PARIETEX¿ HYDROPHILIC ANATOMICAL MESH ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MESH: ACUTE AND CHRONIC PAIN, ALLERGIC REACTIONS TO THE COMPONENTS OF THE PRODUCT, EXTRUSION/EROSION, HEMATOMA, INFECTION, INFLAMMATION, RECURRENCE AND/OR SEROMA. OTHER POSSIBLE COMPLICATIONS INHERENT TO THE SURGICAL PROCEDURE MAY OCCUR, INCLUDING BUT NOT LIMITED TO TROCAR SITE HERNIATION AND ORGAN INJURY. 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 INCLUDING 185 CASES OF TOTAL EXTRAPERITONEAL HERNIOPLASTY FOR INGUINAL HERNIA WAS COMPLETED BETWEEN 2016 AND 2021. THE FOLDING MESH WAS USED FOR INGUINAL HERNIA REPAIR WITHOUT FIXATION. COMPLICATIONS INCLUDED SEROMA IN 4 PATIENTS UNDER THE PIONEER SURGEON GROUP AND NINE (9) PATIENTS IN THE SECOND-GENERATION SURGEON GROUP; CHRONIC PAIN WAS OBSERVED IN FIVE PATIENTS UNDER THE PIONEER GROUP AND ONE PATIENT UNDER THE SECOND-GENERATION GROUP. INTERVENTIONS MENTIONED INCLUDE SEROMA ASPIRATIONS FOR RELIEVING THE DISCOMFORTS OF THE SECOND-GENERATION GROUP. THE MENTORING EFFECTS OF LEARNING CURVE OF TOTAL EXTRAPERITONEAL HERNIOPLASTY: THE CUSUM ANALYSIS OF THE PIONEER AND SECOND-GENERATION SURGEON 10.1007/S00464-025-11729-X.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747707 PARIETEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other