BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 2975489 · Received January 31, 2013

    Report

    Report Number
    9615742-2013-00030
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    November 6, 2007
    Report Date
    January 3, 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). DATE OF REPORT: (B)(4) 2012. DEVICE INFO: AVAULTA ANTERIOR BIOSYNTHETIS SUPPORT SYSTEM. DEVICE MFR: SOFRADIM PRODUCTION, (B)(4). (B)(6).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-00192.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43862 PARIETEX UGYTEX PP ANTERIOR KIT X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION NA ZGH00356

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA POSTERIOR SYSTEM