BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX

    MDR report key: 3040339 · Received September 6, 2012

    Report

    Report Number
    1018233-2012-01130
    Event Type
    Injury
    Date Received
    September 6, 2012
    Report Date
    August 8, 2012
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT'S ATTORNEY HAS ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELVICOL ACELLULAR COLLAGEN MATRIX FTL TISSUE SCIENCE LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention