BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 1842389 · Received September 17, 2010

    Report

    Report Number
    9615742-2010-00041
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    November 5, 2007
    Report Date
    August 20, 2010
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    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

    (B)(4). DATE OF INITIAL REPORT SENT: 09/17/2010. BARD MDR #: 1018233-2010-00095. MDR #: 9615742-2010-00040 (AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM). (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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX UGYTEX PP ANTERIOR KIT X1 AVAULTA ANTERIOR BIOSYNTHETIC SYSTEM FTL SOFRADIM PRODUCTION NA ZGJ00049

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R