Events

OffRoad - Reintroduction Catheter - Record 10341350691 - Hazard Class II (Medium risk) - Technical Name: Catheters - Model H74939202100540 - Affected lots 16514006 (SCHEDULE OF DISTRIBUTION IN ANNEX) 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Boston Scientific do Brasil Ltda.; Boston Scientific Clonmel Limited 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
    1425
  • 날짜
    2014-09-18
  • 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, "affected lots do not have the potential of associated risks, because they are currently valid, without any risk to the patient, so there are no consequences of using these lots."
  • 원인
    The product of offroad reintroduction catheter is composed of two components, contained in an external cardboard box: the balloon catheter of posiconamento and the lancet of the microcatheter. the company has identified that the outer carton contains a validity period of two months beyond the actual expiration date. however, the actual expiration date of each of the components is presented correctly in their individual inner packages.
  • 조치
    The company decided to collect the affected products - Pickup for return to the manufacturer. - Offroad Code 01-2014. (LETTER OF NOTIFICATION TO THE CLIENT IN ANNEX).

Device

OffRoad - Reintroduction Catheter - Record 10341350691 - Hazard Class II (Medium risk) - Technica...

Manufacturer

Boston Scientific do Brasil Ltda.; Boston Scientific Clonmel Limited
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    ANVSANVISA