Events

Alerta De Seguridad para ALL IMPLANTABLE PROSTHESES (Annex)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Silimed Indústria de Implantes 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
    1696
  • Fecha
    2015-10-24
  • 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
    Actions recommended by SILIMED to surgeons and patients • To date, no other health risks have been identified as a result of the implanting of the affected products, in addition to those already expected and declared by Silimed for this type of product. For this reason, patients who already have one of these prostheses need not take any special action. • Wait for new information from the manufacturer and / or health authority. • If you have any questions, please contact assessoria@silimed.com.br. • Do not deploy / do not use affected products. • Quarantine / segregate affected products.
  • Causa
    According to silimed, "on 03/27/2015, silimed received a statement from tuv sud (ocp) about a report of the presence of" foreign body "in some products. from march to september, several contacts took place between silimed and its certifying body (tuv sud), including an unannounced audit on 04/28/2015. soon after this audit, silimed performed an internal analysis on the particles found in the implants that were within the applicable release criteria adopted by the company. tuv sud did not accept the criteria declared by silimed and requested the revision of the documents on clinical evaluation and risk analysis. " on 10/1/2015, anvisa determined the interim injunction of valid lots of all implantable prostheses manufactured by the company and its subsidiary (re nº 2.759, dated 1/10/15). the measure was motivated by the cancellation of the ec certificate of the company by the european sanitary authority; by the results of the inspection performed at the company, from september 28 to 30, 2015, during which nonconformities related to good manufacturing practices were identified, which may be related to the existence of particles on the surfaces of breast implants; by drawing up the interdiction terms of manufacture by the sanitary surveillance center / rj. the certificate of good manufacturing practices was also canceled, in view of noncompliance with the good manufacturing practices required by current legislation (re nº 2,760, dated 1/10/10) ** see annex ** on 05/10 / 2015 int suspended the certification for breast implants produced at the company's manufacturing plant and on 07/12/2015 extended the suspension.
  • Acción
    Suspension of the manufacture of the products and interdiction of all implantable prostheses by the sanitary authority of Brazil (Resolutions RE 2,759 / 2015 and 2,760 / 2015). Alert message by the company (Attachment). Code 2015.1 ### UPDATE 04/18/2016: The company was disindeemed by VISA RJ for the manufacturing and commercialization activities, since it was in technical operational conditions to restart such activities.

Device

ALL IMPLANTABLE PROSTHESES (Annex)

Manufacturer

Silimed Indústria de Implantes Ltda.