BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX

    MDR report key: 3142503 · Received April 24, 2013

    Report

    Report Number
    1018233-2013-01475
    Event Type
    Injury
    Date Received
    April 24, 2013
    Report Date
    November 9, 2015
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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. ASSOCIATED MDR: 1018233-2013-01453.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178247 PELVICOL ACELLULAR COLLAGEN MATRIX Mesh, surgical, polymeric FTL TISSUE SCIENCE LABORATORIES NA 04B17-1

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention AJUST ADJUSTABLE SINGLE INCISION SLING | AJUST ADJUSTABLE SINGLE INCISION SLING