BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLALGEN MATRIX

    MDR report key: 3213479 · Received May 30, 2013

    Report

    Report Number
    1018233-2013-02239
    Event Type
    Injury
    Date Received
    May 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    TISSUE SCIENCE LABS.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADDITIONAL INFO RECEIVED, THE PT HAS EXPERIENCED CRAMPY PELVIC PAIN. ASSOCIATED MDR: 1018233-2013-02238.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238651 PELVICOL ACELLULAR COLALGEN MATRIX FTL TISSUE SCIENCE LABS. NA 04B03-1

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention URETEX SUP URETHRAL SUPPORT SYSTEM