Events

Alerta De Seguridad para 1.SUBTON VTP VERTEBRAL BODY PUNCTURE CELL FOR VERTEBROPLASTY AND BIOPSY - REG. I SUSPEND 80038749001 ;. 2. SUBITON HQ SPLITTER - WITHOUT REGISTRATION ;. 3. SUBITON KNEE KNIFE - WITHOUT REGISTRATION; 4.MAXILOFACIAL - NO REGISTRATION; 5. RADIO-OPACO BONE CASE OF MANUAL APPLICATION - WITHOUT REGISTRATION ;. 6. BASS VISCOSITY STERILE RADIO-OPAQUE BONE CEMENT FOR APPLICATION WITH SYRINGE - WITHOUT REGISTRATION; 7. MANUAL APPLICATION RADIO-OPAQUE BONE CELL - WITHOUT REGISTRATION ;. 8.SUBITON HEMOSCTOR - REG. I SUSPEND 80038740001 ;. 9.SERINGA SUBITON GUN - REG. I SUSPEND 80038749004 ;. 10.SUBIMIX VTP - SUSPENDED REGISTRATION 80038749002 ;. 11.SUBITON BOWL - SUSPENDED REGISTRATION 80038749003 ;. 12.SUBIMIX V - SUSPENDED REGISTRATION 80038749005.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Angioline 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
    1209
  • Fecha
    2012-12-04
  • 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
    See the full text of Resolution - RE Nº 4851, of 12/11/2012, published in the Official Gazette of the Union No. 219 - Section 1, of 13/11/2012 at http://www.in.gov.br/visualiza/index. .jsp? data = 13/11/2012 & journal; = 1 & page; = 127 & total Files = 232.
  • Causa
    All imported products requested by angioline ltda. (cnpj 02.305.681 / 0001-21), had their registrations independed at anvisa, because the company did not have the import activity in its business operation authorization (afe). in this way, anvisa determined as a measure of health interest: (i). the suspension, throughout the national territory, of the importation, dissemination, distribution, sale and use of all lots of all products imported by angioline ltda. - cnpj: 02.305.681 / 0001-21, as they are not registered with anvisa; and (ii). the collection of all units of the products mentioned in item (i) on the market.
  • Acción
    The company must collect all lots of all products.

Device

1.SUBTON VTP VERTEBRAL BODY PUNCTURE CELL FOR VERTEBROPLASTY AND BIOPSY - REG. I SUSPEND 80038749...

Manufacturer

Angioline Ltda
  • Source
    ANVSANVISA