BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 2941561 · Received January 17, 2006

    Report

    Report Number
    9615742-2013-00010
    Event Type
    Injury
    Date Received
    January 17, 2006
    Date of Event
    March 20, 2007
    Report Date
    March 2, 2016
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: (B)(6). DATE OF THIS REPORT: (B)(4) 2012. BRAND NAME: AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM. CATALOG # 486010. URETEX TO2 URETHRAL SUPPORT SYSTEM. (B)(6).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDRS: 1018233-2013-00055 AND 00073.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX UGYTEX PP ANTERIOR KIT X1 AVAULTA ANTERIOR SYSTEM FTL SOFRADIM PRODUCTION NA ZGH00032

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention| O URETEX SUPPORT PP TRANSOBTUR2 KIT X1, SGJ00629| URETEX TO2| URETEX TO2