BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP 15X10CM X1

    MDR report key: 2901032 · Received December 6, 2012

    Report

    Report Number
    9615742-2012-00642
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    February 13, 2009
    Report Date
    November 9, 2012
    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

    (B)(4). ADD'L DATA: DATE OF REPORT - (B)(4) 2012; DEVICE INFO - PELVITEX POLYPROPYLENE MESH; CATALOG #486015; (B)(6).

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. GYNECARE TVT OBTURATOR SYSTEM WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE. ADD'L DATA FROM IMPORTER REPORT: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX UGYTEX PP 15X10CM X1 PELVITEX MESH FTL SOFRADIM PRODUCTION NA PIL00637

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R GYNECARE TVT OBTURATOR SYSTEM