Events

Alerta De Seguridad para Product name: Disposable Stylus Technical Name: Biscuit ANVISA Registration Number: 10229650002 Hazard Class: II Model Affected: Number 11 Serial Numbers Affected: Lot: EEC2756

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Cirúrgica Brasil Comercial e Importadora Ltda.; Cirúrgica Brasil Comercial e Importadora 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
    2268
  • Fecha
    2017-04-12
  • 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
    Identify, by visual inspection, the presence of stains and / or oxidation of the material. The material should not be stored in a humid place or have its packaging wet.
  • Causa
    We were notified on 03/22/2017 via e-mail by covisa (health surveillance coordination) of the municipality of são paulo, to attend on march 2, 2017 a technical expertise at the adolfo lutz institute, in two units collected by the inspectors in the product: disposable stylus no. 11 - batch: eec2756, in which we monitored and observed that the two sealed units presented oxidation in the slide, so far we have not received the report of the analysis. however, after that, we have adopted a voluntary recall in which we send an e-mail and registered letter with ar (acknowledgment of receipt). notes: the 4,900 units produced were sold to a single location, the municipal health fund (sp). we have not received any units so far. the alert is an effective way to reach all health units in the municipality of são paulo (hospitals, ubs, etc.), which may possibly have units of the lot in question. on 03/24/2017, the interim injunction of the lot: eec2756 by suvis / covisa was published in the official gazette of the municipality (official gazette of the city of são paulo).
  • Acción
    Field Action Code 3003/17 triggered under the responsibility of the company Cirúrgica Brasil Comercial e Importadora Ltda. Company will make collection for later return to the manufacturer.

Device

Product name: Disposable Stylus Technical Name: Biscuit ANVISA Registration Number: 10229650002 H...

Manufacturer

Cirúrgica Brasil Comercial e Importadora Ltda.; Cirúrgica Brasil Comercial e Importadora Ltda.