Events

Echelon Reinforced Micro Catheter - Record 80301610021 - Risk Class IV ## Models: 105-5091-150; 145-5091-150; 190-5091-150; 105-5092-150; 5092-150 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Micro Therapeutics, Inc.; EV3 Comércio de Produtos Endovasculares; AUTO SUTURE 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
    1393
  • 날짜
    2014-06-16
  • 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
    According to the company, due to the incorporation of EV3 Comércio de Produtos by Auto Suture do Brasil, it will continue with all actions related to this field action, EV3 of Endovascular Products being the holder of this register. ### UPDATED ON 08/18/2017, fieldwork documentations submitted by the company are archived in the area. If necessary, the area can reassess the action at any time.
  • 원인
    "during the update of the nationalization label of the product in question, the registration number (80102510081) of the holder vr medical imp. and dist. prod. medicos ltda. , to 80301610021, registered by ev3 endovascular products trading of brasil ltda. however, this modification contemplated only the registration number and remained with obsolete registration holder information. " the company also reported that it did not identify risk to the patient and reported that the problem does not interfere with the use of the product.
  • 조치
    It will be corrected in the Nationalization Tag Update field. ## According to the company (Field Action notification form), the products under risk in Brazil are quantified as follows: Total product under risk in Brazil: 795; Marketed quantity: 466; Quantity in stock: 329.

Device

Echelon Reinforced Micro Catheter - Record 80301610021 - Risk Class IV ## Models: 105-5091-150; 1...

Manufacturer

Micro Therapeutics, Inc.; EV3 Comércio de Produtos Endovasculares; AUTO SUTURE DO BRASIL LTDA
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA