Events

Alerta De Seguridad para Actifuse ABX 1-2mm, manufacturer Apatech, models 506005078047 (2,5mm); 506005078048 (5.0mm) and 506005078049 (10.0mm). Record 80253610018. Series Affected: See Annex.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Osteocamp Implantes e Materiais Cirúrgicos Ltda.; Apatech Limited..

¿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
    1736
  • Fecha
    2015-09-21
  • 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 company, in surgical procedures in which the device contacts the cerebrospinal fluid through a hard opening (iatrogenic injury), the use of a medical device that has increased endotoxin levels may increase the typical inflammatory reaction for surgery and contribute to adverse health consequences. There are no reports of adverse events.
  • Causa
    Product with endotoxin level test result above the specified limits, for a stability batch.
  • Acción
    The company that holds the registration will collect and destroy products with an expiration date before 07/29/2017. Product distributors are advised to identify and segregate the product for later collection by the company.

Device

Actifuse ABX 1-2mm, manufacturer Apatech, models 506005078047 (2,5mm); 506005078048 (5.0mm) and 5...

Manufacturer

Osteocamp Implantes e Materiais Cirúrgicos Ltda.; Apatech Limited.
  • Source
    ANVSANVISA