BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL 2CM X 7CM 1.0MM

    MDR report key: 3600539 · Received January 13, 2014

    Report

    Report Number
    9617613-2014-00023
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    September 18, 2009
    Report Date
    December 10, 2015
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4), (IMPORTER).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22851 PELVICOL 2CM X 7CM 1.0MM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC 08B02-9

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other