BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN BIOMESH

    MDR report key: 3142655 · Received March 8, 2013

    Report

    Report Number
    1018233-2013-00661
    Event Type
    Injury
    Date Received
    March 8, 2013
    Report Date
    February 6, 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. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100721 PELVICOL ACELLULAR COLLAGEN BIOMESH FTL TISSUE SCIENCE LABORATORIES NA 02A03

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention