BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX

    MDR report key: 3142298 · Received May 15, 2013

    Report

    Report Number
    1018233-2013-01930
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    July 26, 2017
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, 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 INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215887 PELVICOL ACELLULAR COLLAGEN MATRIX Mesh, surgical, polymeric FTL TISSUE SCIENCE LABORATORIES NA 10B15-9

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention ETHICON-PROLENE MESH| ETHICON-PROLENE MESH