BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX

    MDR report key: 3142371 · Received May 17, 2013

    Report

    Report Number
    1018233-2013-02043
    Event Type
    Injury
    Date Received
    May 17, 2013
    Report Date
    April 19, 2013
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR # 1028233-2013-02045.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219808 PELVICOL ACELLULAR COLLAGEN MATRIX FTM TISSUE SCIENCE LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention PELVISOFT ACELLULAR COLLAGEN BIOMESH