Events

Alerta De Seguridad para KYPHK HV-R HIGH VISCOSITY RADIOPHONE BODY - Registered in Anvisa under the number 80102510396 - Lots: EL21208; EL21708; EL24408; EL24608.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por VR Medical Importadora e Distribuidora de Produtos Médicos Ltda.

¿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
    999
  • Fecha
    2010-01-08
  • 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 company states that it has not received any complaints about this product. Anvisa has no record of adverse event reports or technical complaints regarding this product.
  • Causa
    The manufacturer of the kyphk hv-r radiophic high-vision bone cement product is conducting investigation of complaints regarding the characteristics of this product during its preparation. complaints include a longer time than necessary for cement to achieve adequate viscosity (mass state) and lack of consistency or homogeneity during preparation, as well as at the time of administration with the appropriate instrument (eg the device of cement introduction).
  • Acción
    The company VR Medical Ltda (holder of the registration of the product in Brazil) has already begun issuing letters of notification to the customers who acquired the affected lots. The actions recommended to health professionals are as follows: (1) Check in your inventory the existence of affected products; (2) If a product is found, segregate it, identifying it properly so that it is not inadvertently used; (3) Communicate the company (see Source Description field) by means of a specific form; (4) Send the problem product (s) to VR Medical Ltda. If you work with this product but do not have the batches affected in your inventory, fill out the form anyway and send, stating that you do not have the batches affected.

Device

KYPHK HV-R HIGH VISCOSITY RADIOPHONE BODY - Registered in Anvisa under the number 80102510396 - L...

Manufacturer

VR Medical Importadora e Distribuidora de Produtos Médicos Ltda
  • Source
    ANVSANVISA