BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETEX PRODUCT

    MDR report key: 17436810 · Received August 1, 2023

    Report

    Report Number
    9615742-2023-01109
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    July 3, 2018
    Report Date
    August 1, 2023
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE EVENTS: B. ROMAIN, J.-F. GILLION, P. ORTEGA-DEBALLON, N. MEYER, CLUB HERNIEB. ROMAIN, J.-F. GILLION, P. ORTEGA-DEBALLON, N. MEYER, CLUB HERNIE 2018 CLUB-HERNIE REGISTRY REPORT PARIETEX OPTIMIZED COMPOSITE MESH RECEIVED: 26 FEBRUARY 2018 / ACCEPTED: 22 JUNE 2018 / PUBLISHED ONLINE: 3 JULY 2018 © SPRINGER-VERLAG FRANCE SAS, PART OF SPRINGER NATURE 2018 HERNIA (2018) 22:801¿812 HTTPS://DOI.ORG/10.1007/S10029-018-1796-Y MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM SEPTEMBER 2011 TO MARCH 2014 TO COMPARE THE FOUR MAIN TECHNIQUES OF INGUINAL HERNIA REPAIR IN TERMS OF PATIENT¿S SATISFACTION AND QUALITY OF LIFE AT THE 2-YEAR FOLLOW-UP IN A PROSPECTIVE REGISTRY. 5670 PATIENTS WERE INCLUDED IN THE STUDY: 1092 UNDERGOING LICHTENSTEIN¿S TECHNIQUE, 1259 FOR TRANS-INGUINAL PREPERITONEAL TECHNIQUE (TIPP), 1414 FOR TOTALLY EXTRAPERITONEAL APPROACH (TEP) AND 1905 FOR TRANSABDOMINAL PREPERITONEAL APPROACH (TAPP). COMPLICATIONS INCLUDED SUBCUTANEOUS NON INFECTED FLUID COLLECTIONS (SEROMA), PERIPROSTHETIC NON INFECTED FLUID COLLECTION (SEROMA), NON-PERIPROSTHETIC INFECTED FLUID COLLECTION, PERIPROSTHETIC INFECTED FLUID COLLECTION REQUIRING MESH REMOVAL (REOPERATION), PARIETAL HEMATOMA AND A MESH MIGRATION, SUB OR RETRO-PERITONEAL HEMORRHAGE AND HEMATOMA (PATIENT WITH ON-GOING ANTI-THROMBOTIC AGENT), PERITONITIS, MESH INFECTION AND MESH RECURRENCE (CONFIRMED VIA X-RAY IMAGING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2336131 UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention