BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LVITEX POLYPROPYLENE MESH

    MDR report key: 3192665 · Received April 26, 2013

    Report

    Report Number
    1018233-2013-01602
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    January 7, 2016
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-01596.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183455 LVITEX POLYPROPYLENE MESH Mesh, surgical, polymeric FTL SOFRADIM PRODUCTION NA PIK00695

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention ALIGN TO URETHREAL SUPPORT SYSTEM| ALIGN TO URETHREAL SUPPORT SYSTEM