Alerta De Seguridad para Commercial Name: Disposable Pressure Transducer TPD-48120 HOSP TRADE. Technical Name: Transducer. ANVISA registration number: 80275279004. Class of risk: III. Affected Model: TPD-48120 HOSP TRADE. Serial numbers affected: 314322043, 314147218

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Hosp Trade Do Brasil Eireli; SCW MEDICATH LTD.

¿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
    Following our Risk Management policy of medical-hospital material, we informed all Health Units that purchased the products from lots 314322043 and 314147218 that there is a divergence in the label compared to that registered with Anvisa. In the event of any adverse events related to these lots, please be informed immediately so that we can take appropriate action. 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: 02/19/2016 - 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
    The tpd-48120 disposable pressure transducer hosp trad had its commercialization and use suspended in february 2016 due to divergence of labeling. the product has not been marketed since the suspension and all customers and distributors have been alerted to the problem. the analytical report 695.1p.0 / 2016, issued by lacen-df, identified that the information on the labeling and the contents of the primary packaging differ from the information contained in the product registration. for this reason, anvisa determined the collection of lots 314322043 and 314147218.
  • Acción
    Field Action Code AC01 / 17 triggered under the responsibility of the company Hosp Trade Do Brasil Eireli - EPP. Collection and destruction of the product.