BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    MDR report key: 2768713 · Received September 17, 2012

    Report

    Report Number
    9615742-2012-00421
    Event Type
    Injury
    Date Received
    September 17, 2012
    Date of Event
    July 11, 2007
    Report Date
    October 5, 2018
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT SENT: 09/14/2012. MDR REF # 9615742-2012-00420 (AVAULTA ANTERIOR). NOTE: THIS REPORT CORRESPONDS WITH REPORT #(B)(4) FOR AN "AVAULTA POSTERIOR". DATE OF REPORT: 08/14/2012; DEVICE INFO: AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM; CATALOG #486020; (B)(6).

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL / GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A REPAIR PROCEDURE AND THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. ADD'L DATA FROM IMPORTER REPORT: THE PT'S ATTORNEY HAS ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    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 ZGK00224

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Required Intervention| O AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| PELVILACE TO BIOURETHRAL SUPPORT SYSTEM| AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| PELVILACE TO BIOURETHRAL SUPPORT SYSTEM