Events

Alerta De Seguridad para Product Name: Intracranial Clip for Brain Aneurysm Titanium ADCA //. Risk class: IV (Maximum Risk) //. Technical name: Intracranial clip for cerebral titanium aneurysm //. Registration number: 80116050002 //. Affected model (s): MXT016; MXT058: MXT116; MXT117; MXT143. Lot (s): All lots series 0010-2016; 0011-2016; 0020-2016; 0045-2016; 0046-2016; 0049-2016; 0067-2016; 0068-2016; 0070-2016; 0107-2016; 0126-2016; 0159-2016; 0178-2016; 0187-2016; 0222-2016 //. Attached traceability listing of affected clips

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ADCA – INDÚSTRIA E COMÉRCIO DE MATERIAL CIRÚRGICO 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
    1957
  • Fecha
    2016-08-01
  • 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 ADCA will carry out a correction in the field that will consist of: 1 - Verification and separation of products in the clients' inventories; 2 - field correction of the products with the provision and fixation of the external labels and labels of trail with the correct information. The ADCA will send to the health facilities the traceability labels with the correct registration number along with guidelines for corrections to the medical charts and records of the patients. However, ADCA recommends that patients and users who have used the series of products checked, contact ADCA customer service channels at (31) 3496-1855 or by e-mail sac@adca.ind.br, so that they can learn how and when the traceability labels will be made available for field correction.
  • Causa
    Some batches of adca clips whose references are mxt016; mxt058; mxt116; mxt117 and mxt143 had their external labels and trace labels printed with the wrong registration number. the registration number printed on the outer label and on the trace labels was 80116050003, which corresponds to the adca force clip, when the correct registration number to be printed would be 80116050002, corresponding to the adca aneurysm clips.
  • Acción
    Field Action No. 01/2016 triggered under the responsibility of the company ADCA - INDÚSTRIA E COMÉRCIO DE MATERIAL CIRÚRGICO LTDA. The action in the field aims to promote the correction of the labels and labels of trail of the clips according to the correct registration of the product, ADCA will make a correction in the field that will consist of: 1 - Verification and separation of products in the clients' inventories ; 2 - field correction of the products with the provision and fixation of the external labels and labels of trail with the correct information.

Device

Product Name: Intracranial Clip for Brain Aneurysm Titanium ADCA //. Risk class: IV (Maximum Risk...

Manufacturer

ADCA – INDÚSTRIA E COMÉRCIO DE MATERIAL CIRÚRGICO LTDA
  • Source
    ANVSANVISA