Alerta De Seguridad para Commercial Name: Hemostatic Clip. Technical Name: Clamp. ANVISA registration number: 10175069002. Class of risk: II. Affected Model: 01019502 - Hemostatic Clip. Serial numbers affected: AUTO089768, AUTO089789

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Ventura Biomedica Ltda.

¿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
    As the labeling failure does not pose any risk to the user or the patient when using affected batches, the manufacturer only advises the user to seek guidance: "The Manufacturer Recommends Single Use" - as a way of clarifying its correct use. 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 - Date of identification of the problem by the company: 03/07/2017 - Date of notification notice for Anvisa: 03/08/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner 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
    A fault was identified in the product / lot label (s) below. product: hemostatic clip - registration anvisa nº 10175069002 lots: auto089768, auto089789. the labeling of affected lots is missing the information "the manufacturer recommends single use", which was mistakenly replaced by the terms "single use product" and "do not resterilize", which should not be present on the labeling. does not interfere with the efficacy and functionality of the product and poses no risk to the patient, since its only consequence is to restrict the user to single use of the product, rather than just recommend single use.
  • Acción
    Field Action Code 109/2017 triggered under the responsibility of Ventura Biomedica Ltda. Company will report that there are untrue statements on the product label ..