Alerta De Seguridad para Note (03/28/2018): Based on the 006/2018 / SCVSAT notification from the State Health Department of Paraná, the information on affected lots was rectified and this field action applies to the following lots: . Commercial Name: Protective Cover Bed; ANVISA registration number: 80670160004; Risk class: I; Affected Model: Protective Cover Camouflage Breathalyzer with Ring; Lot: 1702006, 1708033, 1709011 ... Commercial Name: Protective Cover Bed; ANVISA registration number: 80670160004; Risk class: I; Affected Model: Protective Cloak Breathable Videolaparoscopy Cover; Lot: 1709002 ... Commercial Name: Protective Cover Bed; ANVISA registration number: 80670160004; Risk class: I; Affected Model: Ultrasonic Tweezer Protective Cover; Lot: 1709003 ... Trade name: Artrolon Standard; ANVISA registration number: 80670160045; Risk class: II; Model Affected: Artrolon Standard 4V; Lot: 1702007 ... Trade Name: Auxiliary Table Field Bed; ANVISA registration number: 80670160001; Risk class: I; Model Affected: Auxiliary Table Field Bed 90x120cm; Lot: 1702010, 1702011, 1709001, 1709007 ... Trade name: Blue Field in TNT for Auxiliary Table Bed; ANVISA registration number: 80670160006; Risk class: I; Affected Model: Blue Field in TNT for Auxiliary Table Unclosed Bed 130x180cm; Lot: 1702012.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Camahe Indústria e Comércio, Importação e Exportação de Produtos para Saúde 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
    Final customer: segregate the product in stock and return it to the distributor. Distributor: segregate the product that is in stock, make the collection with the customers and return it to the manufacturer. 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: 01/26/2018 - Date of notification notice to Anvisa: 01/30/2018 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
    Due to the notification statement no. 02/2018 of the national health surveillance system (snvs), camahe produtos para saúde is initiating the collection of products that presented sterilization parameters different from those defined in validation and arranged in the company's procedures.
  • Acción
    Field Action Code 001/2018 triggered under the responsibility of the company Camahe Indústria e Comércio, Import and Export of Products for Health Ltda. Will make recollection