Events

Alerta De Seguridad para Several. Introductory Kit 7F. Lot: 185BIO7, 88BIO07 /// Introductory Kit 10F. Lot: 2628B, 2629B, 2637B, 2642B./// Introductory Kit 11F. Lot: 1670C./// Pulsar Pulse Pulsar VDD 870. Series: 207657./// Pacemaker Insignia Model 1198. Series: 102825./// Pacemaker Insignia Model 1298. Series: 151286./// Endocardial Electrode Model 4035. Series: 311672./// Endocardial Electrode Model 4244. Series: 429970, 432590./// Endocardial Electrode Model 4245. Series: 414359, 414402./// Endocardial Electrode Model 4342. Series: 201121./// Fineline Electrode Model 4459. Series: 309880./// Fineline Electrode Model 4473. Series: 318385./// Fineline Electrode Model: 4474. Series: 307118./// Adapter LV-1 IS-1. Lot: 101120, 300661./// Scheduler Model 2920. Series: 30587.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GUIDANT DO BRASIL 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
    750
  • Fecha
    2003-10-30
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    considering the provisions of Article 6 of Law No. 9,782, of January 26, 1999; considering the provisions of Article 6, Item I, and Article 12, paragraph 3, Section III, of Law No. 8,078, of September 11, 1990; considering the Theft Communication of Products for Health of the company GUIDANT DO BRASIL LTDA., File No. 213437 / 03-3; Considering the Boletim de Occurência nº 7844/2003, issued by the 96th Police Station of the Civil Police of the State of São Paulo;
  • Causa
    Stolen health products.
  • Acción
    To determine, as a measure of health interest, the seizure, throughout the national territory, of the products listed below, as they are full batches of stolen health products.

Device

Several. Introductory Kit 7F. Lot: 185BIO7, 88BIO07 /// Introductory Kit 10F. Lot: 2628B, 2629B, ...

Manufacturer

GUIDANT DO BRASIL LTDA
  • Source
    ANVSANVISA