Events

Alerta De Seguridad para Eurospine instruments, HRCID09 models - 3x9 thin lumbar distractor - Lot 883; HRCID10 - Fine lumbar distractor 3.5x10 - Lot 856; HRCID11 - Fine lumbar distractor 3.5x11 - Lot 883, record 10355870048, risk class I.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Biomedica Equipamentos e Suprimentos Hospitalares Ltda.; Eurospine.

¿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
    1813
  • Fecha
    2016-02-01
  • 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
    According to the registry holder, there are no negative impacts related to the patient, because the breaks occurred in the rod near the cable, externally to the patient, without the production of debris. There are also no risks related to lack of surgery, as the manufacturer also offers a series of "monobloc" lumbar distractors (HRCIDx / x references) that can be used instead of the instruments used for this recall.
  • Causa
    According to the record holder there may be breakage of the cable of two surgical instruments that may have been caused by the soldering point or deviations in its form of use.
  • Acción
    Pick up and return to the manufacturer. Action code: 00003. It is recommended to stop immediately the use of the affected products and their segregation, with subsequent return to the importer; the importer will be responsible for returning the instruments affected to the manufacturer, as well as the replacement of the items collected to the customers. It is also recommended that any adverse events noted should be reported to the importer and to the competent health authority.

Device

Eurospine instruments, HRCID09 models - 3x9 thin lumbar distractor - Lot 883; HRCID10 - Fine lumb...

Manufacturer

Biomedica Equipamentos e Suprimentos Hospitalares Ltda.; Eurospine
  • Source
    ANVSANVISA