Events

Alerta De Seguridad para HEM-O-LOK CLIPS (Reg. 80117580001); ENDOSCOPIC APPLICATOR AND HEM-O-LOK CLIPS (Reg. 80117580004); CLIPS DE TITÂNIO HORIZON (Reg. 80117580007). Products Affected: Lots produced until end of July 2008.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Weck Closures Systems.

¿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
    943
  • Fecha
    2008-10-08
  • 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
    The holder of the registration of the products in Brazil (Brasil Import Ltda.) Received from the manufacturer an alert reporting quality control failure in relation to some product packaging - the process of placing the staple cartridge in the blister caused damage in some packages, resulting in holes that compromise the sterility of the products. As a result of the problem, the registry holder, together with the authorized distributor of the product (TC Técnica Cirúrgica Ltda), decided to collect all lots of the products under risk marketed in Brazil. Brasil Import Ltda informed the Tecnovigilance Unit that it has already started sending letters of communication to its clients (see Attachment to Customers - http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_943_carta.pdf) .
  • Causa
    Possibility of holes in the packaging of the staples, which can compromise the sterility of the products.
  • Acción
    The company that owns the product registrations in Brazil (Brasil Import Ltda.) Informed the Anvisa Tecnovigilance Unit (UTVIG / ANVISA) that it suspended the sale and is collecting all the batches of the mentioned products from the market (see Product Description field). The actions recommended to users and distributors of the products are as follows: (a) Check your stock and immediately stop the use / distribution of products at risk; (b) Segregate the products at risk, identifying them correctly to avoid inadvertent use; (c) Return the affected products to the distributor TC Técnica Cirúrgica Ltda (Rua Alberto Folloni 1040 - Bairro Ahú - CEP: 80540-000 - Curitiba / PR); (d) The Stock Status Report and Recognition Form for the aforementioned products must be sent to TC Técnica Cirúrgica Ltda through FAX (41) 3302-2133, even if the affected product is not found in stock.

Device

HEM-O-LOK CLIPS (Reg. 80117580001); ENDOSCOPIC APPLICATOR AND HEM-O-LOK CLIPS (Reg. 80117580004);...

Manufacturer

Weck Closures Systems
  • Source
    ANVSANVISA