Events

Alerta De Seguridad para Trade name: Valvulotomo Hydro Lemaitre Longo. Technical Name: Valvulotomo. ANVISA registration number: 80202919003. Class of risk: II. Affected Model:. Serial numbers affected: ELVH1082V

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
    1985
  • Fecha
    2016-09-14
  • 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
    Recommendations to users and patients: The manufacturer requested the collection of the lot and the proper segregation of the units collected. After the recall, the manufacturer requests that all units be sent to Lemaitre. Regarding the products that were already used, the manufacturer did not request any further action.
  • Causa
    The company clarifies that on 05/08/2016, an official recall statement was received from the manufacturer lemaitre vascular inc, of the product valvulootro hydro longo lemaitre, model 1009-00, lot elvh1082v, of which 5 units were sent to brazil and received on 06/23/2016, according to nf 60436. such collection is due to reported failure to close hoops at the moment of the drive. in some cases, this problem was discovered during use. although there are no reports of adverse events, there is a possibility that a malfunction of the device could damage the vessel at the time of withdrawal. the manufacturer requested the collection of the lot and the proper segregation of the collected units. after the recall, the manufacturer requests that all units be sent to lemaitre. regarding the products that were already used, the manufacturer did not request any further action.
  • Acción
    Field Action No. CWB21 triggered under the responsibility of Tecmedic Comércio de Produtos Médicos Ltda. Risk classification: III (Risk of serious adverse event occurrence) Classification of the field action: Recollection; Return to the manufacturer.

Device

Trade name: Valvulotomo Hydro Lemaitre Longo. Technical Name: Valvulotomo. ANVISA registration nu...

Manufacturer

TECMEDIC COMÉRCIO DE PRODUTOS MÉDICOS LTDA.; Lemaitre Vascular Inc.
  • Source
    ANVSANVISA