BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVISOFT ACELLULAR COLLAGEN MATRIX

    MDR report key: 3142347 · Received May 17, 2013

    Report

    Report Number
    1018233-2013-02054
    Event Type
    Injury
    Date Received
    May 17, 2013
    Report Date
    August 30, 2017
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADDITIONAL INFO RECEIVED, THE PT HAS EXPERIENCED VAGINAL MESH EROSION, VAGINAL DISCHARGE, RECTOCELE AND ABDOMINAL DISCOMFORT. COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219881 PELVISOFT ACELLULAR COLLAGEN MATRIX MESH, SURGICAL, POLYMERIC FTL TISSUE SCIENCE LABORATORIES NA 04B06-1

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention MERSILENE MESH| MERSILENE MESH