BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL (BARD) 8CM X 12CM

    MDR report key: 3244808 · Received February 21, 2013

    Report

    Report Number
    9617613-2013-00057
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 29, 2013
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC
    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

    TRACKING NUMBER (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED PAIN, DISABILITY AND IMPAIRMENT. PLEASE REFER IMPORTER REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77230 PELVICOL (BARD) 8CM X 12CM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC 03B17-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PELVICOL (BARD) 8CMX12CM, 482812, 04B07-9| PELVICOL (BARD) 8CMX12CM, 482812, 04B07-9