BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVITEX POLYPROPYLENE MESH

    MDR report key: 3172327 · Received April 12, 2013

    Report

    Report Number
    1018233-2013-01302
    Event Type
    Injury
    Date Received
    April 12, 2013
    Report Date
    March 13, 2013
    Manufacturer
    SOFRADIM PRODUCTIONS
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    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: 1018233-2013-01303.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159834 PELVITEX POLYPROPYLENE MESH FTL SOFRADIM PRODUCTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PELVITEX POLYPROPYLENE MESH