Alerta De Seguridad para Commercial name: SUROS TriMark Site Identification Device. Technical name: SUROS, TRIMARK LOCAL IDENTIFICATION DEVICE. ANVISA registration number: 80047300529. Risk class: III. Model affected: TRIMARK TD 13-09; TRIMARK TD 13-12; TRIMARK TD 13-MR; TRIMARK TD 36-09; TRIMARK TD 36-12 .. Serial number affected: TRIMARK TD 1309 lots 17K05RF. TRIMARK TD 1312 batches: 16L08RN, 16K24RM, 17A13RL, 17C10RC, 17D17RA, 17H07RA, 17J08RH. TRIMARK TD 13MR batches: 17C02RF, 17C24RB, 17D17RB. TRIMARK TD 3609 batches: 16K20RA, 16K25RK, 17A10RB, 17B02RF, 17C10RD, 17G31RA, 17D24RD, 17F19R, 17G05RA, 17G31RA, 17H14RA, 17K05RB, 17L01RB

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Medstar Importação e Exportação Ltda; HOLOGIC INC..

¿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
    Follow the temporary quarantine exchange or maintenance instructions. There are no health risks to patients. 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: 09/01/2018 - Date of notification notice to Anvisa: 02/15/2018 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
    Hologic manufactures these markers in two different locations (countries) and only the us factory is administratively registered by anvisa. the costa rican plant, also approved in good manufacturing practices under rdc 16/2013 of anvisa, also to the us plant, is still in the process of registering with the agency, awaiting approval of its product registration update. the history of products manufactured in costa rica does not point to any significant quality deviations. although there are no security or performance risks between the products, regardless of their origin, hologic inc has the duty to report what happened to anvisa and inform our customers about the actions recommended and in compliance with brazilian laws. no other hologic product has this logistics problem.
  • Acción
    Field Action Code 10 triggered under the responsibility of Medstar Importação e Exportação Ltda. Quarantine of stock in the customer and distributor with option of exchange of product according to availability