Events

Alerta De Seguridad para Name: Desensibilize Nano-P - Número do Registro: 80172310042 - Technical Name: Subst.P / Treatment Hypersensitivity Dentinaria - Risk Class: II - MEDIUM-RISK - Affected lots: 100415; 040215 (Distribution map in ANNEX)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Dentscare 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
    1688
  • Fecha
    2014-09-16
  • 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 recommends "... It is recommended not to use products from batches 040215 and 100415, because the product may cause irritation to the soft tissues of the mouth. In case of suspected adverse effects mentioned in individuals subject to the use of the product, recommends clinical monitoring until remission of signs and symptoms. "
  • Causa
    Products in batches 040215 and 100415 show changes in ph content which may lead to irritation of the oral soft tissues. according to the company, to evaluate the risks involved were investigated in isolation the raw materials used in the product, but no changes were identified in the standards. we also investigated the production processes where they found that products from the milling process of hydroxyapatite had ph values ​​above the usual.
  • Acción
    Company is promoting the collection of lots under risk in Brazil, according to the Letter to Customers (APPENDIX). Code VPV001

Device

Name: Desensibilize Nano-P - Número do Registro: 80172310042 - Technical Name: Subst.P / Treatmen...

Manufacturer

Dentscare Ltda