BEUDAMED
    FDA Adverse Event Other Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 2896562 · Received November 16, 2012

    Report

    Report Number
    9615742-2012-00581
    Event Type
    Other
    Date Received
    November 16, 2012
    Report Date
    October 22, 2012
    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)(6) 2012, AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM, CATALOG #486010.(B)(6). (B)(4).

    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. ADDITIONAL INFORMATION FROM IMPORTER REPORT: THE PT'S ATTORNEY HAS ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. ASSOCIATED MDR# 1018233-2012-01735.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX UGYTEX PP ANTERIOR KIT X1 AVAULTA ANTERIOR SYSTEM FTL SOFRADIM PRODUCTION NA ZGL00271

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention| O ALIGN TO URETHRAL SUPPORT SYSTEM.| ALIGN TO URETHRAL SUPPORT SYSTEM