BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM

    MDR report key: 3170547 · Received June 12, 2013

    Report

    Report Number
    9617613-2013-00329
    Event Type
    Injury
    Date Received
    June 12, 2013
    Date of Event
    November 3, 2010
    Report Date
    May 20, 2013
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES
    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). (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266939 PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES 07B10-2

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other