BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 2250073 · Received September 9, 2011

    Report

    Report Number
    9615742-2011-00069
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    March 6, 2007
    Report Date
    August 10, 2011
    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
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MDR REF #: 9615742-2011-00067 (AVAULTA POSTERIOR SYSTEM) 9617613-2011-00022 (PELVISOFT COLLAGEN MESH). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT (B)(4) FOR AN "AVAULTA ANTERIOR SYSTEM."

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL / GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT AN ANTERIOR AND POSTERIOR REPAIR PROCEDURE FOR TREATMENT OF PELVIC ORGAN PROLAPSE. THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX UGYTEX PP ANTERIOR KIT X1 AVAULTA POSTERIOR BIOSYNTH SYSTEM FTL SOFRADIM PRODUCTION ZGG00688

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention| O