BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 2021846 · Received March 8, 2011

    Report

    Report Number
    9615742-2011-00020
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    December 19, 2006
    Report Date
    February 9, 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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BARD MDR#: 1018233-2011-00037. MDR REF #: 9617613-2011-00006 (PELVISOFT) 9615742-2011-00021 (AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT (B)(4) FOR AN AVAULTA ANTERIOR SUPPORT SYSTEM.

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A 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 ANTERIOR BIOSYNTH. SYST. FTL SOFRADIM PRODUCTION ZGG00267

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R