BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARIETENE LIGHT PP 20X20CM X1

    MDR report key: 1742549 · Received June 24, 2010

    Report

    Report Number
    9615742-2010-00018
    Event Type
    Malfunction
    Date Received
    June 24, 2010
    Report Date
    June 2, 2010
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HERNIA. ACCORDING TO THE REPORTER: THE MESH COMES FOLDED IN ITS ORIGINAL BOX, AND MADE IT DIFFICULT TO APPROXIMATE THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETENE LIGHT PP 20X20CM X1 SOFRADIM MESH FTL SOFRADIM PRODUCTION SKA00443

    Patients

    Seq Age Sex Outcome Treatment
    1