Events

Alerta De Seguridad para INSTAT MCH HEMOSTATIC MICROFIBRILLARY COLLAGEN, Model 1984 and 1985, Registration no. 80145900849, lots: 1110786, 1110228, 1110227, 1110785, 1110232, 1105179.

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
    1267
  • Fecha
    2013-04-23
  • 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 reports that higher levels of endotoxin may result in fever in the immediate postoperative period. At this time the company is not aware of reports of patient injury or other adverse events in relation to these batches of products. However, it advises that if the service has already implanted or used the collagen sponges affected by this recall, the patient is monitored for fever in the immediate postoperative period according to the standard hospital or clinical protocol.
  • Causa
    The registrant reports that integra lifesciences has detected through a quality assurance review that some of the processes may have deviated from the production process during the manufacture of specific batches of the product. batches of the product in question have been approved in all tests for finished products, are sterile and have been tested and accepted for endotoxin levels. however, due to process drift, they may have been released with higher levels of endotoxin than allowed by product specifications. according to the company's assessment, higher levels of endotoxin may result in fever in the immediate postoperative period. we are not aware of reports of patient injuries or other adverse events in relation to these batches of products.
  • Acción
    1. Make sure you have some of the batches listed on the next page and if so, stop using the product. 2. Remove the service product. 3. Complete the Return Confirmation Form and send this form to the representative. 4. The Customer Service department will contact you for return and replacement of the product. See Letter to the Client at: http: //portal.anvisa.gov.br/wps/wcm/connect/98287d004ff8045699a4ff6d6e8afaaa/Carta_ao_cliente_Instat_MCH.pdf? MOD = AJPERES

Device

INSTAT MCH HEMOSTATIC MICROFIBRILLARY COLLAGEN, Model 1984 and 1985, Registration no. 80145900849...

Manufacturer

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