Alerta De Seguridad para Trade name: Uphold Vaginal Support. Technical Name: Screens. ANVISA registration number: 10341350701. Class of risk: III. Model Affected: M0068317080. Capio Suture Capture Device. Technical Name: Suture Gripper. ANVISA registration number: 10341350717. Class of risk: II. Model Affected: M0068311251. Capio ™ SLIM - Suture Capture Device. Technical Name: Suture Gripper. ANVISA registration number: 10341350777. Risk class: II. Model Affected: M0068318250. Uphold Lite with Capio SLIM - Vaginal Support System. Technical Name: Screen. ANVISA registration number: 10341350779. Risk class: III. Affected Model: M0068318170

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Boston Scientific do Brasil Ltda; Medventure Technology Corporation.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    Based on research and testing performed by the manufacturer, the Product Use Instructions will be updated to reflect the following technique: 1. When loading a set dart into the device, verify that the dart is properly positioned on the capture device. The tip of the dart should not protrude from the tip of the Capio Device; 2. Use light stiffness on the suture while positioning the Capio tip so as to maintain the position of the dart in the capturing device. Avoid excessive counter-traction in the suture, as this has the potential to damage the suture during implantation; Note: The technique of maintaining light suture counter-traction is best described as exerting tension on the suture just sufficient to hold the dart in the capture device. Excessive counter-traction is best described as preventing free movement of the suture during the implant. And read the letter (alert message) carefully and immediately post this information in a visible place near the product to ensure that this information is easily accessible to all users of the device. Pass this notification on to any healthcare professional in your organization who needs to be aware of and to any organization to which potentially affected devices have been transferred (if appropriate). If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 12/13/2018 - Date of notification notice to Anvisa: 02/16/2018 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Causa
    Possibility of breaking and / or rupturing of suture darts.
  • Acción
    Field Action Code 92201802-FA triggered under the responsibility of the company. Boston Scientific do Brasil Ltda. The company will inform customers.