BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX

    MDR report key: 3142591 · Received April 12, 2013

    Report

    Report Number
    1018233-2013-01295
    Event Type
    Injury
    Date Received
    April 12, 2013
    Report Date
    November 9, 2015
    Manufacturer
    TISSUE SCIENCE LABS.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, 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. ASSOCIATED MDR: 101823-2013-01305.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159691 PELVICOL ACELLULAR COLLAGEN MATRIX Mesh, surgical, polymeric FTL TISSUE SCIENCE LABS. NA 02A19

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention GYNECARE TVT| GYNECARE TVT