BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    MDR report key: 2896580 · Received December 13, 2012

    Report

    Report Number
    9615742-2012-00660
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    October 1, 2008
    Report Date
    November 19, 2012
    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).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. AVAULTA PLUS ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM, PELVISOFT ACELLULAR COLLAGEN BIOMESH, ALIGN TO URETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE. ADDITIONAL INFORMATION FROM IMPORTER REPORT: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDRS: 1018233-2012-02003, 1018233-2012-02012-02004, AND 1018233-2012-02005.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R PELVISOFT ACELLULAR COLLAGEN BIOMESH| AVAULTA PLUS ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| ALIGN TO URETHRAL SUPPORT SYSTEM