Events

BLOWTEX TURBO CONDOM. Batch affected: 16JUN11-B. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 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. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1105
  • 날짜
    2011-12-15
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    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.####
  • 원인
    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!.
  • 조치
    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...