BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETEX PRODUCT

    MDR report key: 11891751 · Received May 27, 2021

    Report

    Report Number
    9615742-2021-01392
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    July 14, 2020
    Report Date
    May 26, 2021
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: TOTAL ENDOSCOPIC-ASSISTED LINEA ALBA RECONSTRUCTION (TESLAR) FOR TREATMENT OF UMBILICAL/PARAUMBILICAL HERNIA AND RECTUS ABDOMINUS DIASTASIS IS ASSOCIATED WITH UNACCEPTABLE PERSISTENT SEROMA FORMATION: A SINGLE CENTRE EXPERIENCE SOURCE: HERNIA (2020) 24:1379¿1385 HTTPS://DOI.ORG/10.1007/S10029-020-02266-8 RECEIVED: 20 MAY 2020 / ACCEPTED: 14 JULY 2020 / PUBLISHED ONLINE: 20 JULY 2020 © SPRINGER-VERLAG FRANCE SAS, PART OF SPRINGER NATURE 2020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN MARCH 2018 AND MAY 2019, TOTAL ENDOSCOPIC-ASSISTED LINEA ALBA RECONSTRUCTION WAS PERFORMED TO 21 PATIENTS AND PARIETEX WAS USED TO 3 PATIENTS. THE AIM OF THE STUDY WAS TO ESTABLISH THE RISKS AND BENEFITS OF SAFELY PERFORMING TOTAL ENDOSCOPIC-ASSISTED LINEA ALBA RECONSTRUCTION. ONE PATIENT SUFFERED FROM SEVERE POSTOPERATIVE INFECTED COLLECTION FOLLOWING THE PROCEDURE WHICH REQUIRED FORMAL WASHOUT AND REMOVAL OF THE MESH. OTHER POSTOPERATIVE COMPLICATIONS INCLUDE: SEROMA, CHRONIC PAIN, AND RECURRENCE. PATIENTS WITH SEROMAS UNDERWENT ASPIRATIONS AND REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791837 UNKNOWN PARIETEX PRODUCT FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R