BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    MDR report key: 1408124 · Received June 20, 2009

    Report

    Report Number
    9615742-2009-00037
    Event Type
    Injury
    Date Received
    June 20, 2009
    Date of Event
    May 2, 2007
    Report Date
    October 5, 2018
    Manufacturer
    TREVOUX - USS
    Product Code
    FTL
    PMA / PMN Number
    K051503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    REF MDR#: 9615742-2009-00038 (AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM). BARD MDR REFERENCE#: 1018233-2009-00051. NOTE: THIS REPORT IS ASSOCIATED WITH BARD REPORT #223690 FOR AVAULTA POSTERIOR SYSTEM, BARD PRODUCT. THE ORIGINAL PROCEDURE WAS PERFORMED AT THE HOSPITAL.

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROLOGICAL. ACCORDING TO THE REPORTER, THE PT UNDERWENT AN ANTERIOR REPAIR AND POSTERIOR REPAIR PROCEDURE FOR TREATMENT OF PELVIC ORGAN PROLAPSE. ALLEGEDLY, THE PT EXPERIENCED DAMAGE TO AN ORGAN SYS AND PAIN. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. THE DEVICE REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE DOCTOR, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX UGYTEX PP POSTERIOR KIT X1 AVAULTA POSTERIOR BIOSYNTHETIC SYS FTL TREVOUX - USS ZGH00267

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Required Intervention| O