BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL (BARD) 8CM X 12CM

    MDR report key: 3232224 · Received July 8, 2013

    Report

    Report Number
    9617613-2013-00472
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    February 3, 2005
    Report Date
    June 12, 2013
    Manufacturer
    COVIDIEN, FORMERLY TISSUE
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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: STRESS UI /PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. GYNECARE TVT WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308718 PELVICOL (BARD) 8CM X 12CM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE 04B14-2

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other PELVICOL ACELLULAR COLLAGEN MATRIX: LOT #04B21-1| PRODUCT #482812, EXP DATE: 09/24/2009| PELVICOL ACELLULAR COLLAGEN MATRIX: LOT #04B21-1| PRODUCT #482812, EXP DATE: 09/24/2009