BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX

    MDR report key: 3142628 · Received February 20, 2013

    Report

    Report Number
    1018233-2013-00473
    Event Type
    Injury
    Date Received
    February 20, 2013
    Report Date
    January 25, 2013
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADDITIONAL INFO RECEIVED, THE PT HAS EXPERIENCED PERIURETHRAL SCARRING, MIXED URINARY INCONTINENCE, CYSTOCELE, EROSION OF MESH SLING, EROSION OF MESH SLING REMOVAL WITH URETHRAL RECONSTRUCTION, AND ANTERIOR VAGINAL WALL PROLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75428 PELVICOL ACELLULAR COLLAGEN MATRIX FTL TISSUE SCIENCE LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention