BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    MDR report key: 3231709 · Received July 12, 2013

    Report

    Report Number
    9615742-2013-00745
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    May 14, 2007
    Report Date
    June 13, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTP
    PMA / PMN Number
    K051503
    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 PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323473 PARIETEX UGYTEX PP POSTERIOR KIT X1 AVALUTA POSTERIOR SYSTEM OTP SOFRADIM PRODUCTION ZGJ00366

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other