BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX

    MDR report key: 3182847 · Received June 14, 2013

    Report

    Report Number
    1018233-2013-02445
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 16, 2013
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE PT'S ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272248 PELVICOL ACELLULAR COLLAGEN MATRIX FTL TISSUE SCIENCE LABORATORIES NA 02A23

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention