Events

RENEGADE MICROCATETER - Registered in Anvisa under the number 10341350227. Models / Lots - see attached relation. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Boston Scientific do Brasil Ltda. 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
    984
  • 날짜
    2009-09-22
  • 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
    The product listing included in this "Voluntary Customer Gather Notification" provides a list of all UPN codes and affected lots, as well as their catalog numbers and expiration date range for those affected products. Based on our records, the attached Verification and Traceability Response Form contains product information for all affected products purchased by you. When inquiring whether you have affected product in your stock, please refer to your Verification and Traceability Response Form and the affected products listed in this Attachment Notice. Anvisa is following this action.
  • 원인
    It has been reported that the bag sealing (top sealing) may be broken. if a compromised sealing is not detected and a compromised sterile catheter is used in medical procedures, there is a risk of adverse health consequences, including bacteremia or infection and, in more extreme cases, septic endocartitis, organ failure, and death.
  • 조치
    The actions recommended to users of the product are as follows: (1) Immediately stop the use of products listed in the attached list; (2) Locate products with the affected models / batches in your inventory and segregate them in a safe place. (3) Complete and return the account verification and traceability response form to Boston Scientific do Brasil Ltda. - A / C Caroline Yin - Fax: (011) 5502-8510; (4) Pack, identify the box with affected products and request collection by calling (011) 5502-8583.

Device

RENEGADE MICROCATETER - Registered in Anvisa under the number 10341350227. Models / Lots - see at...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA