BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETEX PRODUCT

    MDR report key: 17511988 · Received August 11, 2023

    Report

    Report Number
    9615742-2023-01152
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    January 21, 2023
    Report Date
    August 11, 2023
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: UNK-PERMACOL, UNKNOWN PERMACOL PRODUCT (LOT#UNKNOWN) UNK-PERMACOL, UNKNOWN PERMACOL PRODUCT (LOT#UNKNOWN) UNKNOWN PARIETEX, UNKNOWN PARIETEX PRODUCT (LOT#UNKNOWN) REFERENCE: BERDEL AKMAZ, 2023 SURGICAL ENDOSCOPY (2023). HIATAL HERNIA RECURRENCES AFTER LAPAROSCOPIC SURGERY: EXPLORING THE OPTIMAL TECHNIQUE. SPRINGER SCIENCE+BUSINESS MEDIA, LLC, PART OF SPRINGER NATURE 2023, HTTPS://DOI.ORG/10.1007/S00464-023-09907-W, PP.4431¿4442. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EVALUATED THE RECURRENCE RATE OF HIATAL HERNIA IN PATIENTS WHO UNDERWENT A LAPARO SCOPIC FUNDOPLICATION BETWEEN 2012 AND 2019. THERE WERE 307 PATIENTS INCLUDED IN THE STUDY, WITH 208 PATIENTS WHO UNDERWENT A TOUPET FUNDOPLICATION AND 97 PATIENTS WHO UNDERWENT A NISSEN FUNDOPLICATION. FOR REINFORCEMENT IN THE NISSEN FUNDOPLICATION GROUP, A MESH WAS USED IN FOUR PATIENTS AND PERMACOL WAS USED IN THREE PATIENTS. WHILE FOR TOUPET FUNDOPLICATION GROUP, A MESH WAS USED IN ONE PATIENT AND PERMACOL WAS USED IN ONE PATIENT. HERNIA RECURRENCE OCCURRED IN ONE PATIENT IN EACH MESH GROUP. RECURRENCE WAS DIAGNOSTICALLY CONFIRMED WITH A COMPUTED TOMOGRAPHY AND/OR BARIUM SWALLOW. THE CAUSES OF RECURRENCES ARE REPORTED TO BE MULTI-FACTORIAL AND ARE ASSOCIATED WITH THE TYPE OF CRUROPLASTY PERFORMED, PREEXISTING MEDICAL CONDITIONS AND THE SIZE OF THE HIATAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233459 UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention SEE H10