BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 4834103 · Received June 20, 2009

    Report

    Report Number
    9615742-2009-00043
    Event Type
    Injury
    Date Received
    June 20, 2009
    Date of Event
    April 23, 2007
    Report Date
    May 22, 2009
    Manufacturer
    TREVOUX - USS
    Product Code
    FTL
    PMA / PMN Number
    KD51503
    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

    (B)(4). MDR REFERENCE #: 9615742-2009-00050 (AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM). BARD MDR REFERENCE#: 10182333-2009-00060. THIS REPORT IS ASSOCIATED WITH BARD REPORT # 223108 FOR AVAULTA POSTERIOR SYSTEM, BARD PRODUCT ID: 486010. THE ORIGINAL PROCEDURE WAS PERFORMED AT (B)(4).

    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 SYSTEM AND PAIN. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. THE DEVICE REMAINS IMPLANTED. ADDITIONAL INFO 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 ANTERIOR KIT X1 AVAULTA ANTERIOR BIOSYNTHETIC SYSTEM FTL TREVOUX - USS ZGJ00188

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention| O