BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    MDR report key: 2999996 · Received February 21, 2013

    Report

    Report Number
    9615742-2013-00098
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    August 9, 2007
    Report Date
    January 25, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTP
    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 INFORMATION FROM THE IMPORTER REPORT: DATE OF THIS REPORT: 01/23/2013; BRAND NAME: AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM; CATALOG: 486020; (B)(6).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ETHICON - GYNECARE TVT SECURE WERE REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE. ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-00391.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75338 PARIETEX UGYTEX PP POSTERIOR KIT X1 AVAULTA POSTERIOR SYSTEM OTP SOFRADIM PRODUCTION NA ZGK00071

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ETHICON - GYNECARE TVT SECUR| AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM