BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMACOL 20X40 1.5MM

    MDR report key: 3416069 · Received September 9, 2013

    Report

    Report Number
    9617613-2013-00874
    Event Type
    Malfunction
    Date Received
    September 9, 2013
    Date of Event
    July 12, 2013
    Report Date
    August 12, 2013
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HERNIA. ACCORDING TO THE REPORTER: ONGOING HEMATOMA (MILD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447203 PERMACOL 20X40 1.5MM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC 11B15-6

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR