BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACEELUAR COLLAGEN MATRIX

    MDR report key: 3152087 · Received May 29, 2013

    Report

    Report Number
    1018233-2013-02225
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    April 30, 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 ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-02224.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233722 PELVICOL ACEELUAR COLLAGEN MATRIX FTL TISSUE SCIENCE LABORATORIES NA 04B01-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PELVICOL ACELLULAR COLLAGEN MATRIX| BOSTON SCIENTIFIC OBTRYX