BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    MDR report key: 1912603 · Received November 24, 2010

    Report

    Report Number
    9615742-2010-00054
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    August 22, 2006
    Report Date
    October 29, 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: (B)(4) 2010. BARD MDR#: 1018233-2010-00126. MDR REF#: 9615742-2010-00055 (AVAULTA ANTERIOR 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 POSTER REPAIR PROCEDURE FOR TREATMENT OF URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. ALLEGEDLY, THE PT EXPERIENCE DAMAGE TO AN ORGAN SYSTEM AND PAIN. PT HAS UNDERGONE OR UNDERGO CORRECTIVE SURGERY OR SURGERIES. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX UGYTEX PP POSTERIOR KIT X1 AVAULTA POSTERIOR BIOSYNTHETIC SYST FTL SOFRADIM PRODUCTION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R