Events

Alerte De Sécurité sur BLOWTEX TURBO CONDOM. Batch affected: 16JUN11-B.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par 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..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1105
  • Date
    2011-12-15
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.####
  • Cause
    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!.
  • Action
    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...