BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX

    MDR report key: 9752085 · Received February 25, 2020

    Report

    Report Number
    9615742-2020-00451
    Event Type
    Injury
    Date Received
    February 25, 2020
    Report Date
    September 13, 2024
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    PMA / PMN Number
    K982532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (UPDATED ALL CODES, ADDED PATIENT CODES, IMF CODES AND IME E2402: "INGUINAL NERVE ENTRAPPING"). 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

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INGUINAL NERVE ENTRAPPING, CHRONIC PAIN, INFLAMMATION AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED ILIOINGUINAL NEURECTOMY, REVISION SURGERY AND RIGHT GROIN EXPLORATION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE: BARD VENTRALEX MESH FOR UMBILICAL HERNIA, (0010301, LOT # HUTG1789). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INGUINAL NERVE ENTRAPPING, CHRONIC PAIN, INFLAMMATION AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED ILIOINGUINAL NEURECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211934 PARIETEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS TECR1510 SJF00451

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention