BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX INTRODUCER NEEDLE X1

    MDR report key: 3231602 · Received July 12, 2013

    Report

    Report Number
    9615742-2013-00803
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    November 15, 2004
    Report Date
    June 20, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K041176
    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).

    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. PELVISOFT ACELLULAR COLLAGEN BIOMESH WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321485 URETEX INTRODUCER NEEDLE X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION 24211ITO

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other