BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVITEX POLYPROPYLENE MESH

    MDR report key: 3152143 · Received May 24, 2013

    Report

    Report Number
    1018233-2013-02193
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    COMPLAINT #(B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-02136.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230529 PELVITEX POLYPROPYLENE MESH FTL SOFRADIM PRODUCTION NA P24126G3

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention BOSTON SCIENTIFIC TVT SUBURETHRAL SLING| PELVISOFT ACELLULAR COLLAGEN BIOMESH