BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARIETEX

    MDR report key: 22104396 · Received May 29, 2025

    Report

    Report Number
    22104396
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    May 19, 2025
    Report Date
    May 21, 2025
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    MESH THAT WAS OPENED WOULD NOT LAY CORRECTLY WHERE IT NEEDED TO BE. MESH KEPT CURLING AND NOT LAYING FLAT. OPENED NEW MESH OF SAME SIZE AND PLACED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703653 PARIETEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION PCO4VP PYL0385X

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male