BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX

    MDR report key: 3142379 · Received May 6, 2013

    Report

    Report Number
    1018233-2013-01730
    Event Type
    Injury
    Date Received
    May 6, 2013
    Report Date
    April 8, 2013
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE, PER ADDITIONAL INFORMATION RECEIVED, THE PT HAS EXPERIENCED INCONTINENCE, PELVIC PAIN, AND PAIN DURING INTERCOURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197689 PELVICOL ACELLULAR COLLAGEN MATRIX FTL TISSUE SCIENCE LABORATORIES NA 02A20

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention