BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    MDR report key: 3014202 · Received March 12, 2013

    Report

    Report Number
    9615742-2013-00175
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    September 14, 2007
    Report Date
    February 12, 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). BRAND NAME: AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM. (CATALOG #): 486020. (B)(6).

    Description of Event or Problem · 1

    PROCEDURE TYPE: 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: ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDRS: 1018233-2013-00666 AND 00667.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104508 PARIETEX UGYTEX PP POSTERIOR KIT X1 AVAULTA POSTERIOR SYSTEM FTL SOFRADIM PRODUCTION NA ZGJ00163

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R URETEX SUPPORT PP TRANSOBTUR2 KIT X1, URETEXTO2,| URETEX TO2 URETHRAL SUPPORT SYSTEM| PARIETEX UGYTEX PP ANTERIOR KIT X1, UGYKA,| (B)(4)| (B)(4)| AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM