BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL 6 X 8 CM

    MDR report key: 3250718 · Received July 19, 2013

    Report

    Report Number
    9617613-2013-00569
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    August 21, 2006
    Report Date
    June 27, 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: PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338030 PELVICOL 6 X 8 CM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE 05B13-9

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other