BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSATEX

    MDR report key: 12661865 · Received October 19, 2021

    Report

    Report Number
    9615742-2021-02335
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    February 15, 2021
    Report Date
    October 19, 2021
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    UDI-DI
    10884521532267
    PMA / PMN Number
    K150091
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: ENHANCED-VIEW TOTALLY EXTRAPERITONEAL APPROACH IN EMERGENCY VENTRAL INCISION HERNIA REPAIR: A CASE REPORT SOURCE: SWISS MED WKLY. 2021;151:W20423 PP1-4. (B)(4). 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 IN 2021, 30 DAYS POST-OPERATIVE TO EMERGENCY LAPAROSCOPIC VENTRAL HERNIA REPAIR VIA ENHANCED-VIEW TOTALLY EXTRAPERITONEAL (ETEP) APPROACH, THERE WAS A SYMPTOMATIC SEROMA CAUSING PAIN IN THE SURGICAL SITE, WHICH NEEDED SURGICAL EVACUATION, BUT WAS COMPLETELY RESOLVED AT 1-YEAR FOLLOW-UP WITH NO SYMPTOMS AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559246 VERSATEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS VTX3030M 10884521532267

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention