BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARIETEX

    MDR report key: 21831026 · Received April 11, 2025

    Report

    Report Number
    9615742-2025-00347
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    November 24, 2024
    Report Date
    April 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

    D10. CONCOMITANT PRODUCTS: UNKABSTACK, UNKNOWN ABSORBATACK (LOT UNKNOWN); UNKABSTACK, UNKNOWN ABSORBATACK (LOT UNKNOWN) WEI-CHANG LEE, CHING-WEI HUANG, LE-WEI FAN, YUN-REN LI, YING-HSU CHANG, YU-CHAO HSU, CHUNG-YI LIU. "COMPARISON OF ANATOMICAL POLYESTER MESH WITHOUT FIXATION AND CONVENTIONAL FLAT MESH WITH FIXATION IN LAPAROSCOPIC TOTAL EXTRAPERITONEAL REPAIR FOR INGUINAL HERNIA." HERNIA (2025) 29:128. HTTPS://DOI.ORG/10.1007/S10029-024-03231-5. 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 COMPARED THE OUTCOMES OF CONVENTIONAL MESH WITH FIXATION VERSUS POLYESTER MESH WITHOUT FIXATION IN LAPAROSCOPIC TOTAL EXTRAPERITONEAL REPAIR BETWEEN SEPTEMBER 2015 AND JUNE 2023. IN 36 PATIENTS (67 HERNIAS), HYDROPHILIC ANATOMICAL MESH WITHOUT FIXATION WAS USED. POSTOPERATIVE COMPLICATIONS RELATED TO THE MESH INCLUDE PAIN IN FOUR PATIENTS AND SEROMA IN TWO PATIENTS. COMPARISON OF ANATOMICAL POLYESTER MESH WITHOUT FIXATION AND CONVENTIONAL FLAT MESH WITH FIXATION IN LAPAROSCOPIC TOTAL EXTRAPERITONEAL REPAIR FOR INGUINAL HERNIA 10.1007/S10029-024-03231-5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270005 PARIETEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other