Events

Alerta De Seguridad para Trade Name: ENXERTO PERFECTHA DERM. Active Principle: Hyaluronic Acid. N. Anvisa Reg.: 80230190001

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Comédix Comércio de Produtos Médicos e Farmacêuticos Ltda; Hangzhou Gallop Biological Products Co. 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
    825
  • Fecha
    2006-02-15
  • 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
    Anvisa will continue to follow the case, in order to ensure that health products marketed in Brazil have the safety and efficacy necessary for the good performance of the product.
  • Causa
    Comédix comércio de produtos médicos e farmacêuticos ltda is initiating recall of perfectra derm graft product due to printing errors detected on the label material of the packages and their respective package inserts. the company informs that such inaccuracies do not imply any influence on the composition, quality or efficacy of the produtis, nor do they lead to compromise of its application or administration. lots / date of fab / val date / imported quantity: lot 050826 / fab. 08-2005 / val. 08-2007 / 950 units; lot 050411 / fab. 04-2005 / val 04-2007 / 50 units. presentation: 1.0 ml quantity sold in brazil: lot 050826 - 900 units lot 050411 - 18 units.
  • Acción
    The company Comédix: - notified the incident to Anvisa; - Sent an advertising message, published in the Jornal do Comércio Brasil, on 01/03/2006, with a communiqué informing the event and calling on those who have intact units of the product to contact the SAC on 0800 999 139, so that it is feasible and replaced. UPDATE OF INFORMATION (05/31/2006) - THE COMPANY REPORTED THAT THERE WAS NO RETURN OF ANY UNIT OF THE COMMERCIALIZED PRODUCT, WHICH IS IN QUESTION. SO, AFTER ABOUT 03 MONTHS OF THE ANNOUNCEMENT, THE COMPANY REPORTS THAT IT IS GIVING THE CASE CLOSED. THE COMPANY ALREADY CORRECTED THE PRINT ERROR.

Device

Trade Name: ENXERTO PERFECTHA DERM. Active Principle: Hyaluronic Acid. N. Anvisa Reg.: 80230190001

Manufacturer

Comédix Comércio de Produtos Médicos e Farmacêuticos Ltda; Hangzhou Gallop Biological Products Co...
  • Source
    ANVSANVISA