BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 2971217 · Received February 6, 2013

    Report

    Report Number
    9615742-2013-00088
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    June 22, 2007
    Report Date
    January 11, 2013
    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 TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: ASSOCIATED MDRS: 1018233-2013 AND 1018233-2013-00308.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51381 PARIETEX UGYTEX PP ANTERIOR KIT X1 AVAULTA ANTERIOR SYSTEM FTL SOFRADIM PRODUCTION NA ZG100104

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| R URETEX SUP URETHRAL SUPPORT SYSTEM| AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA POSTERIOR SUPPORT SYSTEM