BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETEX

    MDR report key: 8573166 · Received May 2, 2019

    Report

    Report Number
    9615742-2019-01567
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    December 11, 2018
    Report Date
    May 2, 2019
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE ROBOTIC-ASSISTED VENTRAL HERNIA REPAIR WITH SURGICAL MESH: HOW I DO IT AND CASE SERIES OF EARLY EXPERIENCE SOURCE ANZ J SURG, 2019 (1-7) DATE OF PUBLICATION: 11 DECEMBER 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE OF THE STUDY PERFORMED FROM MAY 2015 TO AUGUST 2018, 50 PATIENTS UNDERWENT ROBOTIC ASSISTED VENTRAL HERNIA REPAIR POST -OPERATIVE A PROCEDURE, OUT OF 50 PATIENTS, 2 PATIENTS HAD A RECURRENCE WITH A EXTENDED HOSPITAL STAY OF 3 DAYS, 2 HAD A MINOR WOUND INFECTION, 1 HAD ASPIRATION PNEUMONIA, 1 HAD ILEUS ARRHYTHMIAS, 1 HAD ILEUS AND SEROMA, AND 1 HAD ARRHYTHMIA AND ABDOMINAL WALL HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368221 UNKNOWN PARIETEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| O