BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 3111786 · Received April 18, 2013

    Report

    Report Number
    9615742-2013-00299
    Event Type
    Injury
    Date Received
    April 18, 2013
    Date of Event
    July 11, 2007
    Report Date
    March 22, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTO
    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).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT' ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. BOSTON SCIENTIFIC ADVANTAGE TRANSVAGINAL WERE REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168311 PARIETEX UGYTEX PP ANTERIOR KIT X1 AVAULTA ANTERIOR SYSTEM OTO SOFRADIM PRODUCTION ZGI00300

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other UGYKA| PARIETEX UGYTEX PP ANTERIOR KIT X1: LOT # ZGK00071