Events

Alerta De Seguridad para BLOWTEX TURBO CONDOM. Batch affected: 16JUN11-B.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por FÁBRICA DE ARTEFATOS DE LATEX BLOWTEX LTDA. Endereço: Estrada Municipal Dr. Irineu de Resende s/n° Cx. Postal 01 Alumínio/SP CEP 18125-000. Telefone e FAX: Tel: 11- 4715-4100/ Fax: 11-4715-4109..

¿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
    1105
  • Fecha
    2011-12-15
  • 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
    Due to complaints about product disruption, the company assessed the need to collect the batch due to the risk of condom disruption during use, resulting in unwanted pregnancy or contagion of sexually transmitted diseases. Use the following telephone numbers and e-mail addresses to contact the company regarding this problem: Phone: 11- 5536-4669; consumer@blowtex.com.br; Camila Alves - e-mail: camila.alves@ansell.com; Tiago Andrade - e-mail: tiago.andrade@ansell.com; Cristiano Cisneros - email: cristiano.cisneros@ansell.com. #### UPDATE - 10/26/2012 - The Certifying Body - Instituto Falcão Bauer da Qualidade - directs Official 2682/2012, where it reports the regularization of the company with approval in the tests after the implementation of corrective actions, as demonstrated by the ELA report /L-226.676/1/2/12.####
  • Causa
    A possible manufacturing problem has been identified in lot 16jun11-b of the blowtex turbo condom, which may affect the strength of the product making it unsuitable for use. view updated in clarifications!.
  • Acción
    According to the product registration holder, corrective measures were taken by the factory to ensure the homogenization of the lubricant solution used in the product. This will prevent the problem from occurring again. As for the existing units in commerce, the company has already initiated a collection action and has already issued an alert to the population, through messages published in widely circulated media. Users are advised to check the batch number printed on the condom package before using the product - if the batch is at risk (16JUN11-B), the product should not be used but replaced with another. Distributors are advised to segregate affected products from their inventories by identifying them as unfit for use and to contact the Blowtex registration holder as soon as possible.

Device

BLOWTEX TURBO CONDOM. Batch affected: 16JUN11-B.

Manufacturer

FÁBRICA DE ARTEFATOS DE LATEX BLOWTEX LTDA. Endereço: Estrada Municipal Dr. Irineu de Resende s/n...