BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 3001103 · Received March 5, 2013

    Report

    Report Number
    9615742-2013-00153
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    May 30, 2007
    Report Date
    February 7, 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). ADDITIONAL INFO FROM THE IMPORTER REPORT: (B)(6) 2013; AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM, CATALOG: 486010; (B)(6). ATTORNEY.

    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 INFO FROM THE IMPORTER REPORT: ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92713 PARIETEX UGYTEX PP ANTERIOR KIT X1 AVAULTA ANTERIOR SYSTEM FTL SOFRADIM PRODUCTION NA ZGI00697

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other| R