Events

Retiro De Equipo (Recall) de Boston Scientific Urogynaecological Surgical MeshesAdvantage/Advantage Fit, Transvaginal Sling, Lynx, Suprapubic Sling, Obtryx, Transobturator Sling (Curved/Halo), Obtryx II with PrecisionBlue Design, Solyx SIS, Single Incision Sling; Uphold LITE Vaginal Support with Capio SLIM Pinnacle LITE Pelvic Floor Repair Kit, Posterior with Capio SLIM, Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device; XenformTM Soft Tissue Repair Matrix

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Boston Scientific Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-00120-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-19
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00120-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    The tga carried out a clinical review of urogynaecological surgical mesh implants which have highlighted the importance of:- appropriate patient selection;- surgeon experience; and- the need for fully informed patient consent.Boston scientific (bsc) has made important updates to the directions for use (dfu) for the meshes. these updates are based on bsc’s review, as well as input from the tga. contraindications, precautions, and adverse events have been updated to present the most comprehensive and up to date information available.
  • Acción
    The DFU for all Boston Scientific's surgical meshes were reviewed and updated to ensure consistency and alignment of language across the product lines. The customer letter identifies what amendments have to made to the DFU. This action has been closed-out on 27/01/2017.

Device

Boston Scientific Urogynaecological Surgical MeshesAdvantage/Advantage Fit, Transvaginal Sling, L...
  • Modelo / Serial
    Boston Scientific Urogynaecological Surgical MeshesAdvantage/Advantage Fit, Transvaginal Sling, Lynx, Suprapubic Sling, Obtryx, Transobturator Sling (Curved/Halo), Obtryx II with PrecisionBlue Design, Solyx SIS, Single Incision SlingARTG 104326Uphold LITE Vaginal Support with Capio SLIM Pinnacle LITE Pelvic Floor Repair Kit, Posterior with Capio SLIM, Upsylon Y Mesh Kit with Colpassist Vaginal Positioning DeviceARTG 150342XenformTM Soft Tissue Repair MatrixARTG 174878
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA