BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 2930438 · Received December 18, 2012

    Report

    Report Number
    9615742-2012-00665
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    December 5, 2005
    Report Date
    April 5, 2018
    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). ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: (B)(4) 2012, AVAULATA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM, CATALOG #: 486010, (B)(6).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DISABILITY AND IMPAIRMENT. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM, URETEX TO WERE REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE. IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DISABILITY AND IMPAIRMENT. ASSOCIATED MDRS: 1018233-2012-02046 AND 1018233-2012-02045.

    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 PFG00396

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention URETEX TO URETHRAL SUPPORT SYSTEM| AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM