BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP 15X10CM X1

    MDR report key: 3232222 · Received July 8, 2013

    Report

    Report Number
    9615742-2013-00741
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 3, 2006
    Report Date
    June 12, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K033376
    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). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (IMPORTER).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PELVITEX POLYPROPYLENE MESH AND BOSTON SCIENTIFIC OBTRYX HALO SYSTEM WERE REPORTED TO BE USED/ IMPLANTED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310839 PARIETEX UGYTEX PP 15X10CM X1 PELVITEX MESH FTL SOFRADIM PRODUCTION P24253G3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other