Events

Alerta De Seguridad para Trade name: Valvulotome Hydro Longo Lemaitre ANVISA Registration Number: 80202919003 Hazard Class: II Affected Model: 1009-00 Serial Numbers Affected: ELVH1102V

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Tecmedic Comércio de Produtos Médicos Ltda; Lemaitre Vascular 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
    2187
  • Fecha
    2017-02-07
  • 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
    For products that were already used in patient, the manufacturer did not request any further action.
  • Causa
    Tecmedic comércio de produtos médicos ltda., on 05/02/2017 received notification of collection of lot elvh1102v of reference 1009-00 of the product valvulotomo hydro longo lemaitre, registered with anvisa under nº 80202919003. this collection was initiated due to to reported problems of failure of the rims to close when the device was triggered. in some cases, this problem was discovered in use and led to damage in the vessel. if the blades are locked in the open position, the device must be removed in the open position. removal of the unassembled device may cause damage to the vein or during use or when the blades pass through the vessel. the manufacturer lemaitre requested the immediate recall of the valvulotomo hydro long lemaitre, model 1009-00, lot elvh1102v and the proper segregation of the parts. after this recall, the manufacturer requested that all units be shipped to lemaitre. for the valvuloto hydro long lemaitre units of the elvh1102v batch used, the manufacturer did not request any further action. tecmedic imported 23 units from the affected lot.
  • Acción
    Field Action Code CWB 02/2017 triggered under the responsibility of the company Tecmedic Comércio de Produtos Médicos Ltda. Company will collect.

Device

Trade name: Valvulotome Hydro Longo Lemaitre ANVISA Registration Number: 80202919003 Hazard Class...

Manufacturer

Tecmedic Comércio de Produtos Médicos Ltda; Lemaitre Vascular Inc
  • Source
    ANVSANVISA