BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX

    MDR report key: 3213490 · Received May 30, 2013

    Report

    Report Number
    1018233-2013-02234
    Event Type
    Injury
    Date Received
    May 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    TISSUE SCIENCE LABS.
    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 INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238678 PELVICOL ACELLULAR COLLAGEN MATRIX FTL TISSUE SCIENCE LABS. NA 03B16-3

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention PELVILANCE BIOURETHRAL SUPPORT SYSTEM| PELVICOL ACELLULAR COLLAGEN MATRIX