BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL 2CM X 7CM 1.0MM

    MDR report key: 3158897 · Received June 3, 2013

    Report

    Report Number
    9617613-2013-00311
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    September 11, 2003
    Report Date
    May 15, 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). EXEMPTION NUMBER: 2013003. 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. IN-FAST BONE ANCHOR WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243295 PELVICOL 2CM X 7CM 1.0MM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE 02B04

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other