BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX

    MDR report key: 3142565 · Received April 18, 2013

    Report

    Report Number
    1018233-2013-01376
    Event Type
    Injury
    Date Received
    April 18, 2013
    Report Date
    March 19, 2013
    Manufacturer
    TISSUE SCIENCE LABS.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT'S ATTORNEY 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
    168589 PELVICOL ACELLULAR COLLAGEN MATRIX FTL TISSUE SCIENCE LABS. NA 03B18-1

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention WITH USP#1| SUTURE (X2)| POLYBUTESTER MONOFILAMENT NON-ABSORBABLE| PRECISION SPEED TAC TRANSVAGINAL ANCHOR SYS