BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PELVICOL PRODUCT

    MDR report key: 3242944 · Received July 12, 2013

    Report

    Report Number
    9617613-2013-00502
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 29, 2005
    Report Date
    June 17, 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

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: STRESS UI/PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PT ALLEGED INJURY. PELVISOFT WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324875 UNKNOWN PELVICOL PRODUCT PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other