BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL 4 X 12 CM

    MDR report key: 3111748 · Received April 16, 2013

    Report

    Report Number
    9617613-2013-00151
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    June 23, 2003
    Report Date
    December 3, 2015
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). .

    Description of Event or Problem · 1

    PROCEDURE TYPE: STRESS UI /PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PT'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
    163890 PELVICOL 4 X 12 CM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE 02A19

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other