BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACCELLULAR COLLAGEN MATRIX

    MDR report key: 3142572 · Received April 10, 2013

    Report

    Report Number
    1018233-2013-01262
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 11, 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

    THE PATIENT'S ATTORNEY 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
    154250 PELVICOL ACCELLULAR COLLAGEN MATRIX FTL TISSUE SCIENCE LABORATORIES NA 03B11

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention PRECISION TWIST TRANSVAGINAL ANCHOR