Events

Alerta De Seguridad para KIT CONFIDENCE PLUS - Kit Confidence Plus (11 cc) - Record no. 80145901323, lots: HPBB2B, HPBB2G, HPCB7B, HPDBGY, HPDBBL.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde 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
    1266
  • Fecha
    2013-04-22
  • 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
    If the devices have been transferred to other organizations, we ask that you provide the organization's name and contact information on the Field Correction Confirmation Form and forward a copy of this Field Security Notification to the organization to which the device was transferred. If you have further questions or concerns about the information contained in this Field Safety Notice, please contact the representative.
  • Causa
    The company informs that during the injection of cement, water in the hydraulic pump leaks into the pump body after passing through the piston, resulting in loss of pressure and inability to continue to inject cement. this may result in delayed surgery to prepare another kit or to close the procedure earlier than intended, which could result in the patient having to undergo additional anesthesia as a result of another surgical procedure.
  • Acción
    The company requests that the above-described combinations of product code and batch number be removed from service and contact your DePuy Synthes Spine * representative to arrange product return, credit and / or replacement. They further request that this information be distributed to relevant personnel in the services, including surgeons who may have received the product, the subject of this notification. See Letter to the Client at: http: //portal.anvisa.gov.br/wps/wcm/connect/4d1748804ff803369991ff6d6e8afaaa/KIT_CONFIDENCE_PLUS_FORMULARIO_DE_CONFIRMACAO_2_.pdf? MOD = AJPERES

Device

KIT CONFIDENCE PLUS - Kit Confidence Plus (11 cc) - Record no. 80145901323, lots: HPBB2B, HPBB2G,...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda